Trial Outcomes & Findings for Safety and Efficacy Study of IV Artesunate to Treat Malaria (NCT NCT00298610)
NCT ID: NCT00298610
Last Updated: 2019-10-01
Results Overview
Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
48 hours
Results posted on
2019-10-01
Participant Flow
Thirty adult subjects with uncomplicated malaria were recruited from the endemic malarious region of Nyanza province in Kenya came to the New Nyanza Medical Center or sub-location recruitment sites.
Participant milestones
| Measure |
Artesunate and Malarone
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of IV Artesunate to Treat Malaria
Baseline characteristics by cohort
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 9.4 • n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Tribe = Luo
|
27 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Tribe = Luyha
|
2 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Tribe = Other
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
Kenya
|
30 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Percentage of parasite change at 48 hours post dose
Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases
Outcome measures
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Change in Percentage of Parasites Detected at 48 Hours
|
99.998 percentage of parasite change
Standard Deviation 0.0006
|
SECONDARY outcome
Timeframe: 24 and 48 hours post dosePopulation: Percentage of parasite clearance within the first 24 and 48 hours post dose of intravenous artesunate
The target variable is detection (percentage) of asexual stage parasites of Plasmodium falciparum malaria in bloodstream by Giemsa - stained microscopy of thick and thin blood smears
Outcome measures
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Percentage of Parasite Clearance
48 hours post dose
|
99.998 percentage of parasite clearance
Standard Deviation 0.0006
|
|
Percentage of Parasite Clearance
24 hours post dose
|
99.421 percentage of parasite clearance
Standard Deviation 1.365
|
SECONDARY outcome
Timeframe: Within 48 hours post dosePopulation: Summary of subject with fever clearance, defined as first sustained absence of fever (\<37.5C for least 24 hours)
Temperature is measured by oral digital thermometers, and fever clearance time is defined as the first time with resolution of fever (\<37.5C) sustained for 24 hours
Outcome measures
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Number of Subjects With Fever Clearance
|
29 Participants
|
SECONDARY outcome
Timeframe: up to 14 daysDetermine the safety (defined as severity of AE's using the Common Toxicity Criteria)
Outcome measures
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Safety - Severity of Adverse Events
Mild
|
123 Number of adverse events
|
|
Safety - Severity of Adverse Events
Moderate
|
17 Number of adverse events
|
|
Safety - Severity of Adverse Events
Severe
|
6 Number of adverse events
|
SECONDARY outcome
Timeframe: up to 14 daysDetermine the safety (defined as relationship to study drug of AE's and SAE's)
Outcome measures
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Safety - Adverse Events Relationship to Study Drug
None or remote
|
89 Number of adverse events
|
|
Safety - Adverse Events Relationship to Study Drug
Possible, probable, definate
|
57 Number of adverse events
|
SECONDARY outcome
Timeframe: up to 14 daysDetermine the safety (defined as severity of SAE's using the Common Toxicity Criteria)
Outcome measures
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Safety - Severity of Serious Adverse Events (SAE's)
Mild
|
0 Number of events
|
|
Safety - Severity of Serious Adverse Events (SAE's)
Moderate
|
0 Number of events
|
|
Safety - Severity of Serious Adverse Events (SAE's)
Severe
|
1 Number of events
|
SECONDARY outcome
Timeframe: Up to 14 daysDetermine the safety (defined as relationship to study drug of SAE's)
Outcome measures
| Measure |
Artesunate and Malarone
n=30 Participants
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Safety - Serious Adverse Event (SAE) Relationship to Study Drug
None or Remote
|
0 Number of events
|
|
Safety - Serious Adverse Event (SAE) Relationship to Study Drug
Possible, Probable, Definate
|
1 Number of events
|
Adverse Events
Artesunate and Malarone
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Artesunate and Malarone
n=30 participants at risk
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
Other adverse events
| Measure |
Artesunate and Malarone
n=30 participants at risk
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
5/30 • Number of events 5 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
13.3%
4/30 • Number of events 4 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/30 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/30 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Vascular disorders
Hypotension
|
30.0%
9/30 • Number of events 9 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
General disorders
Pyrexia
|
23.3%
7/30 • Number of events 7 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
General disorders
Chills
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
General disorders
Infusion site pain
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
General disorders
Chest pain
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
General disorders
Oedema peripheral
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Cardiac disorders
Bradycardia
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Cardiac disorders
Tachycardia
|
16.7%
5/30 • Number of events 5 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Viral infection
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Abscess
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Furuncle
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/30 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Hordeolum
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Oral candidiasis
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Infections and infestations
Viraemia
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Nervous system disorders
Headache
|
26.7%
8/30 • Number of events 8 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Nervous system disorders
Syncope vasovagal
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 3 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/30 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/30 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Gastrointestinal disorders
Gingival pain
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
3/30 • Number of events 3 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypoea
|
0.00%
0/30 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
6.7%
2/30 • Number of events 2 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/30 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Eye disorders
Conjunctivitis
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
|
Investigations
Bilirubin decreased
|
3.3%
1/30 • Number of events 1 • 14 Days
AE's were solicited using standardized questionnaires at each clinic visit (Days 0 - 14+2)
|
Additional Information
Shon A. Remich, MD
Walter Reed Army Institute of Research
Phone: 254-733-628-670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place