Uganda Malaria Surveillance Project - Comparison of amodiaquine plus artesunate and artemether-lumefantrine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44534980

Enrollment

400

Registered

2005-11-28

Start date

2004-12-14

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 treatment with amodiaquine + artesunate (AQ + AS) or artemether + lumefantrine (AL). Subjects in the AQ + AS arm will also receive placebo tablets to ensure that the nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 1-10 years 2. Weight >10 kg 3. Fever (>37.5 °C axillary) or history of fever in the previous 24 hours 4. Provision of informed consent and agreement to follow-up for 28 days 5. P. falciparum mono-infection 6. Parasite density >2000/µl and <200,000/µl

Exclusion criteria

Exclusion criteria: 1. Previously enrolled in this study 2. History of serious side effects to study medications 3. Evidence of a concomitant febrile illness 4. Evidence of severe malaria or danger signs 5. Repeated vomiting of study medications on day 0

Design outcomes

Primary

Measure	Time frame
Primary outcome will be based on the risk of clinical rescue therapy. Pairwise comparisons between regimens will be made based on a per-protocol analysis.	—

Secondary

Measure	Time frame
1. Risk of clinical treatment failure 2. Risk of parasitological rescue therapy 3. Risk of parasitological treatment failure 4. 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 5. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on day 2 and day 3 6. Change in mean haemoglobin from day 0 to 28 or day of repeat therapy 7. Proportion of subjects lacking gametocytes on day 0 with gametocytaemia on any follow-up day 8. 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 9. 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 treatment failure 2. Risk of parasitological rescue therapy 3. Risk of parasitological treatment failure 4. 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 5. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on day 2 and day 3 6. Change in mean haemoglobin from day 0 to 28 or day of repeat therapy 7. Proportion of subjects lacking gametocytes on day 0 with gametocytaemia on any follow-up day 8. 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 9. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures

—

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026