Chloroquine Alone or in Combination for Malaria in Children in Malawi
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.
Timeline
- Start
- 2007-02
- Primary completion
- 2009-08
- Completion
- 2012-09
Outcome
Missed primary endpoint
registry Chloroquine Plus Artesunate vs CQ Monotherapy; p = 0.8097; Risk Ratio (RR) 1.0413 (95% CI 0.7497 to 1.4463) NCT00379821 ↗
registry Chloroquine Plus Atovaquone-Proguanil vs CQ Monotherapy; p = 0.3767; Risk Ratio (RR) 1.1623 (95% CI 0.8333 to 1.6211) NCT00379821 ↗
registry CQ Plus Azithromycin vs CQ Monotherapy; p = 0.6277; Risk Ratio (RR) 1.0707 (95% CI 0.7708 to 1.4872) NCT00379821 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 4 mg/kg | — |
| Subject | Atovaquone-proguanil | Unknown | — | — |
| Subject | Azithromycin | Small molecule | 30 mg/kg | — |
| Subject | Chloroquine | Small molecule | 5 mg/kg | — |