Treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso: comparison of amodiaquine sulfadoxine-pyrimethamine with Coartem

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54261005

Enrollment

521

Registered

2006-05-05

Start date

2005-08-02

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

Subjects will be randomized to receive treatment with amodiaquine sulfadoxine pyrimethamine or artemether lumefantrine. Subjects in amodiaquine group will receive placebo to ensure the same number of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =6 months 2. Fever (=37.5 or history of fever in the last 24 hours) 3. Provision of informed consent 4. P. falciparum mono infection 5. Parasite density >2000 microliters and =200,000 microliters

Exclusion criteria

Exclusion criteria: 1. Evidence of severe malaria 2. History of side effects to the investigational product 3. Pregnancy 4. Repeated vomiting of study medication on day 0 5. Hemoglobin <5 g/Dl 6. Evidence of concomitant febrile illness

Design outcomes

Primary

Measure	Time frame
The risk of clinical and parasitological treatment failure after 28 days of follow-up. Pairwise comparisons between regimens will be made on based on a per protocol analysis.	—

Secondary

Measure	Time frame
1. Risk of clinical failure after 14 days of follow-up 2. Risk of rescue therapy after 28 days of follow-up 3. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature >37.5 °C) or patient report of fever on days 1, 2, 3 4. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on days 2 and 3 5. Change in mean hemoglobin from day 0 to 28 or day of repeat therapy 6. Proportion gametocytemic: presence versus absence of gametocytes on any follow-up thick blood smear; proportion gametocytemic on days 2, 3, 7, 14, 21, and 28 7. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period, excluding treatment failures 8. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures	—

Measure

Time frame

1. Risk of clinical failure after 14 days of follow-up 2. Risk of rescue therapy after 28 days of follow-up 3. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature >37.5 °C) or patient report of fever on days 1, 2, 3 4. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on days 2 and 3 5. Change in mean hemoglobin from day 0 to 28 or day of repeat therapy 6. Proportion gametocytemic: presence versus absence of gametocytes on any follow-up thick blood smear; proportion gametocytemic on days 2, 3, 7, 14, 21, and 28 7. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period, excluding treatment failures 8. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures

—

Countries

Burkina Faso

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 8, 2026