CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 640 enrolled
Drug / intervention
Atovaquone-proguanil +3 moredrug
Likely dose
Atovaquone-proguanil 62.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00379821
NCT00379821Phase 3Completed

A Longitudinal Study of Chloroquine as Monotherapy or in Combination With Artesunate, Azithromycin or Atovaquone-Proguanil to Treat Malaria in Children in Blantyre, Malawi

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 25, 2006·Updated Aug 11, 2014

In Brief

A Phase 3 clinical trial evaluating Atovaquone-proguanil, Artesunate, and 2 other interventions for Plasmodium Falciparum Infection. Completed, enrolled 640 participants across 1 site.

Detailed Summary

Malaria is a sickness caused by a germ that can get into a person's body when a mosquito bites them. It can cause fever, headache, body aches and weakness. It can even cause death, especially in children. When malaria is treated with the appropriate medicine(s), it can be cured completely. The purpose of this study is to find out if it is better to use chloroquine alone or in combination with another drug to most effectively treat malaria. About 640 children with malaria, aged 6 months to 5 years of age, from the Blantyre Malaria Project Research Clinic at the Ndirande Health Center in Malawi will be in the study. They will be treated with either chloroquine alone or a combination of chloroquine plus another medication (azithromycin or artesunate or atovaquone-proguanil) every time they get malaria for a year. Blood samples will be collected and tested at least every 4 weeks. Participants will be involved in the study for 1 year.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalawi
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 25, 2006
Enrollment StartFeb 1, 2007
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 19.8 years ago

Interventions

Atovaquone-proguanildrug

Atovaquone-proguanil: once a day for 3 days, Pediatric tablet: 62.5 mg/25 mg, Full strength tablet: 250 mg/100 mg

Artesunatedrug

Artesunate: 4mg/kg once a day for 3 days, 50 mg tablet

Azithromycindrug

Azithromycin 30 mg/kg once a day for 3 days, 200 mg/5cc suspension

Chloroquinedrug

Chloroquine: 10 mg/kg on days 0 and 1, 5 mg/kg/day on day 2, 100 mg tablet.