Clinical trial NCT00118807: Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children
Official title: Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: malaria treatment
artemisinin based combination therapy
Plasmodium falciparum
pragmatic trial
effectiveness
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: National Malaria Control Programme, The Gambia
First posted: 2005-07-12
Enrollment: 1800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.

Detailed description: Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.

Eligibility criteria: Inclusion Criteria:

* Presentation at health centre with febrile illness
* Monoinfection with P. falciparum
* Parasitaemia \>=500/microlitre
* Fever or history of fever

Exclusion Criteria:

* Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia \>200,000/ul)
* Severe malnutrition
* Clinically evident concomitant disease
* PCV \<20%
* History of allergy to the study medications
* Residence outside the study area and hence difficult to follow up

Primary outcomes:
measure: Clinical failure by day 28
measure: Incidence of adverse events
Secondary outcomes:
measure: Compliance with treatment regimen
measure: Parasitological failure by day 28
measure: Clinical failure by day 14
measure: Parasitological failure rate by day 14
measure: Mean PCV on day 28
measure: Gametocyte carriage rates
measure: Transmissibility after treatment
Other outcomes:
Locations:
city: Banjul
country: Gambia
facility: Medical Research Council Laboratories
Study officials:
affiliation: Medical Research Council
name: Sam K Dunyo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Paul J Milligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: