Trial Outcomes & Findings for Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure (NCT NCT04706130)
NCT ID: NCT04706130
Last Updated: 2026-06-03
Results Overview
Number of patients experiencing recurrence as measured by microscopy and PCR and time to recurrence
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
3 months
Results posted on
2026-06-03
Participant Flow
Participant milestones
| Measure |
Control Group
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) without primaquine
|
Low Primaquine Group
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.25 mg/kg/day of primaquine
|
High Primaquine Group
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.5 mg/kg/day of primaquine
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
49
|
46
|
|
Overall Study
COMPLETED
|
59
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
Reasons for withdrawal
| Measure |
Control Group
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) without primaquine
|
Low Primaquine Group
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.25 mg/kg/day of primaquine
|
High Primaquine Group
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.5 mg/kg/day of primaquine
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
2
|
|
Overall Study
Mixed infection
|
0
|
0
|
1
|
Baseline Characteristics
Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
Baseline characteristics by cohort
| Measure |
Arm1: No Primaquine
n=59 Participants
Enrolled patients will only received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days)
Artesunate: All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites
|
Arm2: Primaquine Low Dose
n=45 Participants
Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.25 mg/kg/day for 14 days (starting at day 7)
Primaquine: After treatment of the blood stage infection, enrolled participants will receive either no primaquine, a low dose of primaquine or a high dose of primaquine against liver parasites
Artesunate: All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites
|
Arm3: Primaquine High Dose
n=43 Participants
Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.50 mg/kg/day for 14 days (starting at day 7)
Primaquine: After treatment of the blood stage infection, enrolled participants will receive either no primaquine, a low dose of primaquine or a high dose of primaquine against liver parasites
Artesunate: All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=20 Participants
|
38 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
114 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20 years
n=20 Participants
|
23 years
n=20 Participants
|
22 years
n=40 Participants
|
21 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=20 Participants
|
41 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=20 Participants
|
45 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Cambodia
|
59 participants
n=20 Participants
|
45 participants
n=20 Participants
|
43 participants
n=40 Participants
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of patients experiencing recurrence as measured by microscopy and PCR and time to recurrence
Outcome measures
| Measure |
Control Group
n=59 Participants
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) without primaquine
|
Low Primaquine Group
n=45 Participants
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.25 mg/kg/day of primaquine
|
High Primaquine Group
n=43 Participants
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.5 mg/kg/day of primaquine
|
|---|---|---|---|
|
Number of Patients Experiencing P. Vivax Recurrence
|
48 Participants
|
11 Participants
|
2 Participants
|
Adverse Events
Low Primaquine Group
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
High Primaquine Group
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Primaquine Group
n=45 participants at risk
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.25 mg/kg/day of primaquine
|
High Primaquine Group
n=43 participants at risk
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.5 mg/kg/day of primaquine
|
Control Group
n=59 participants at risk
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) without primaquine
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • From enrollment until end of follow-up (up to 90 days)
|
0.00%
0/43 • From enrollment until end of follow-up (up to 90 days)
|
0.00%
0/59 • From enrollment until end of follow-up (up to 90 days)
|
|
General disorders
Fever
|
17.8%
8/45 • From enrollment until end of follow-up (up to 90 days)
|
14.0%
6/43 • From enrollment until end of follow-up (up to 90 days)
|
33.9%
20/59 • From enrollment until end of follow-up (up to 90 days)
|
|
Infections and infestations
Influenza-like syndromes
|
8.9%
4/45 • From enrollment until end of follow-up (up to 90 days)
|
11.6%
5/43 • From enrollment until end of follow-up (up to 90 days)
|
20.3%
12/59 • From enrollment until end of follow-up (up to 90 days)
|
|
General disorders
Headache
|
6.7%
3/45 • From enrollment until end of follow-up (up to 90 days)
|
4.7%
2/43 • From enrollment until end of follow-up (up to 90 days)
|
10.2%
6/59 • From enrollment until end of follow-up (up to 90 days)
|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
2/45 • From enrollment until end of follow-up (up to 90 days)
|
0.00%
0/43 • From enrollment until end of follow-up (up to 90 days)
|
0.00%
0/59 • From enrollment until end of follow-up (up to 90 days)
|
|
Blood and lymphatic system disorders
Methemoglobin increase
|
11.1%
5/45 • From enrollment until end of follow-up (up to 90 days)
|
37.2%
16/43 • From enrollment until end of follow-up (up to 90 days)
|
0.00%
0/59 • From enrollment until end of follow-up (up to 90 days)
|
|
Blood and lymphatic system disorders
Hemoglobin decrease
|
22.2%
10/45 • From enrollment until end of follow-up (up to 90 days)
|
27.9%
12/43 • From enrollment until end of follow-up (up to 90 days)
|
49.2%
29/59 • From enrollment until end of follow-up (up to 90 days)
|
|
Blood and lymphatic system disorders
Neutrophil decrease
|
2.2%
1/45 • From enrollment until end of follow-up (up to 90 days)
|
2.3%
1/43 • From enrollment until end of follow-up (up to 90 days)
|
3.4%
2/59 • From enrollment until end of follow-up (up to 90 days)
|
Additional Information
David Serre
University of Maryland School of Medicine
Phone: (410) 706-7983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place