Trial Outcomes & Findings for Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE) (NCT NCT03178643)
NCT ID: NCT03178643
Last Updated: 2024-04-23
Results Overview
The primary endpoint is the cumulative incidence of clinical malaria expressed as episodes per person-year at risk. Time at risk will begin when study participants are randomized and receive study drug (i.e. begin chemoprevention) and end when participants reach the end of the observation period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
246 participants
Primary outcome timeframe
12 months
Results posted on
2024-04-23
Participant Flow
Potential participants will be screened for inclusion in the existing pediatric. Currently, SCA patients are cared for in two parallel clinics: 1) the pediatric medical officer staffs a weekly SCA clinic, and 2) the AMPATH HematoOncology outreach team staffs a monthly 2-day SCA clinic at HBCH. Potential participants will be screened for eligibility. If they meet all inclusion criteria and do not meet any exclusion criteria, they will be offered enrollment following informed consent.
Participant milestones
| Measure |
Proguanil Oral Tablet
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
Sulfadoxine/Pyrimethanine-Amodiaquine
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
83
|
82
|
|
Overall Study
COMPLETED
|
75
|
67
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
Baseline characteristics by cohort
| Measure |
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
81 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
246 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
4.8 years
STANDARD_DEVIATION 2.6 • n=99 Participants
|
4.3 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
4.7 years
STANDARD_DEVIATION 2.6 • n=206 Participants
|
4.6 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
131 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Tribe/Ethnic Group · Luo
|
80 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
244 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Tribe/Ethnic Group · Luhya
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
Kenya
|
81 participants
n=99 Participants
|
83 participants
n=107 Participants
|
82 participants
n=206 Participants
|
246 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary endpoint is the cumulative incidence of clinical malaria expressed as episodes per person-year at risk. Time at risk will begin when study participants are randomized and receive study drug (i.e. begin chemoprevention) and end when participants reach the end of the observation period.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Incidence of Clinical Malaria Per Patient Year
|
3.05 episodes/patient year
|
1.36 episodes/patient year
|
0.04 episodes/patient year
|
SECONDARY outcome
Timeframe: 12 monthsE.g., hemoglobin \<5.5 g/dL
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Severe Anemia
|
9 Participants
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPositive rapid diagnostic test (RDT).
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Severe Malaria
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPatient admitted to hospital for malaria with confirmed positive RDT.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Hospitalization for Malaria
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsLM-positive malaria defined as the reported presence of P. falciparum parasites detected by LM irrespective of RDT or other detection results.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Light Microscopy (LM)-Positive Malaria
|
11 Participants
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsDefined as the receipt of antimalarials for suspected malaria episodes that were not confirmed by any objective diagnostic test.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Unconfirmed Malaria
|
25 Participants
|
40 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 12 monthsDefined as death during hospitalization for malaria with positive RDT.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Fatal Malaria
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsDefined as the presence of parasites during routine follow-up visits as detected by PCR in patients without fever or a history of recent fever.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Asymptomatic Parasitization
|
20 Participants
|
9 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPain lasting two hours or more without obvious cause.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Painful Events
|
28 Participants
|
30 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPain or tenderness with or without swelling of the hands or feet.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Dactylitis
|
57 Participants
|
37 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 12 monthsReceipt of RBCs (red blood cells) from any caregiver for any indication.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
|---|---|---|---|
|
Number of Participants With Transfusions
|
7 Participants
|
4 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 monthsDefined as a new pulmonary infiltrate and at least 3 of the following findings: chest pain, temperature elevation \> 38.5°C, tachypnea, wheezing, or cough.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
|
Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
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|---|---|---|---|
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Number of Participants With Acute Chest Syndrome
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3 Participants
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0 Participants
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1 Participants
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SECONDARY outcome
Timeframe: 12 monthsHospitalization at HBCH or any other inpatient facility with any admitting diagnosis.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
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Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
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Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
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|---|---|---|---|
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Number of Participants With All-cause Hospitalization
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52 Participants
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40 Participants
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47 Participants
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SECONDARY outcome
Timeframe: 12 monthsDeath by any cause.
Outcome measures
| Measure |
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 Participants
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
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Dihydroartemisinin-Piperaquine (DP)
n=82 Participants
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
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Proguanil Oral Tablet
n=81 Participants
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
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|---|---|---|---|
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All-cause Deaths
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7 Participants
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1 Participants
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2 Participants
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SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not collected.
presence of SNPs in parasite genes that confer resistance to the study drugs
Outcome measures
Outcome data not reported
Adverse Events
Proguanil Oral Tablet
Serious events: 22 serious events
Other events: 0 other events
Deaths: 2 deaths
Sulfadoxine/Pyrimethanine-Amodiaquine
Serious events: 22 serious events
Other events: 0 other events
Deaths: 7 deaths
Dihydroartemisinin-Piperaquine (DP)
Serious events: 19 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Proguanil Oral Tablet
n=81 participants at risk
Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis
Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
|
Sulfadoxine/Pyrimethanine-Amodiaquine
n=83 participants at risk
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) is a combination therapy comprised of sulfadoxine and pyrimethamine (two antifolate antimicrobials) co-administered with amodiaquine. This medication is taken on a monthly basis.
Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ): Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
|
Dihydroartemisinin-Piperaquine (DP)
n=82 participants at risk
DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.
Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:
Weight (kg) No. of 40/320mg tabs DP daily for 3 days
≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
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|---|---|---|---|
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Blood and lymphatic system disorders
Painful Crisis
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27.2%
22/81 • Number of events 33 • 12 months
This protocol collected only SUSARs (Suspected Unexpected Serious Adverse Reactions) and deaths.
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26.5%
22/83 • Number of events 28 • 12 months
This protocol collected only SUSARs (Suspected Unexpected Serious Adverse Reactions) and deaths.
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23.2%
19/82 • Number of events 30 • 12 months
This protocol collected only SUSARs (Suspected Unexpected Serious Adverse Reactions) and deaths.
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Blood and lymphatic system disorders
Anemia
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12.3%
10/81 • Number of events 12 • 12 months
This protocol collected only SUSARs (Suspected Unexpected Serious Adverse Reactions) and deaths.
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14.5%
12/83 • Number of events 14 • 12 months
This protocol collected only SUSARs (Suspected Unexpected Serious Adverse Reactions) and deaths.
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8.5%
7/82 • Number of events 7 • 12 months
This protocol collected only SUSARs (Suspected Unexpected Serious Adverse Reactions) and deaths.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place