Treatment of Uncomplicated Malaria in Benin

Uncomplicated Malaria Clinical Trial

Official title:

Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460369
• Other study ID #: Malariallada
• Status: Completed
• Phase: N/A
• First received: April 12, 2007
• Last updated: April 11, 2008
• Start date: April 2007
• Est. completion date: November 2007

Study information

• Verified date: April 2008
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised.

The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome.

Expected total enrollment: 225 patients

Study start: April 2007; expected completion: December 2007

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 119 Months

Eligibility

Inclusion Criteria:

• 6-119 months old

• fever or history of fever of less than 24 hours

• p falciparum parasitemia > 1000 trophozoïtes/µL

• informed consent signed

Exclusion Criteria:

• < 5 kg

• danger or severity signs of malaria

• known underlying chronic disease

• Hb < 5g/dL

• adequate malaria treatment taken within 3 days before visit

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Uncomplicated Malaria

Intervention

Drug:
• sulfadoxine-pyrimethamine
tablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake
• artemether-lumefantrine
tablets 20/120 mg 1 tablet twice daily for 3 days below 15 kg of bodyweight 2 tablets twice daily for 3 days below 24 kg of bodyweight 3 tablets twice daily for 3 days below 35 kg of bodyweight
• amodiaquine-artesunate coformulation
one 25mg/67,5mg tablet, once daily for 3 days below 9 kg one 50/135mg tablet, once daily for 3 days below 18 kg

Locations

Country	Name	City	State
Benin	Centre de santé	Allada

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy		day 28	No
Secondary	effectiveness comparisons (PCR corrected)		day 14 and day 42	No
Secondary	incidence of adverse events		day 42	Yes