Chloroquine Alone or in Combination for Malaria in Children in Malawi

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Artemisinins; Artesunate; Atovaquone; Atovaquone, proguanil drug combination; Azithromycin; Chloroquine; Chloroquine diphosphate; Proguanil

Criteria

Inclusion Criteria:

• Subjects aged greater than or equal to 6 months to 5 years presenting to Ndirande Health Centre with signs or symptoms consistent with malaria including, but not limited to, one or more of the following:

1. fever at the time of evaluation (axillary temperature greater than or equal to 37.5 degrees Celsius by digital thermometer)

2. report of fever within the last two days

3. clinically profound anemia (conjunctival or palmar pallor)

4. headache

5. body aches

6. abdominal pain

7. decreased intake of food or fluids

8. weakness

• Weight greater than or equal to 5kg.

• Positive malaria smear for P. falciparum mono-infection with parasite density 2,000-200,000/mm^3.

• Planning to remain in the study area for 1 year.

• Willingness to return for four-weekly routine visits, as well as unscheduled sick visits.

• Parental/guardian consent for each participant.

Exclusion Criteria:

• Signs of severe malaria: One or more of the following:

1. hemoglobin less than or equal to 5 g/dL

2. prostration

3. respiratory distress

4. bleeding

5. recent seizures, coma or obtundation (Blantyre coma score < 5)

6. inability to drink

7. persistent vomiting

• Known allergy or history of adverse reaction to chloroquine (CQ), artesunate, azithromycin, erythromycin or atovaquone-proguanil (AP)

• Chronic medication with any antibiotic or anti malarial medication

• Previous enrollment in this study

• Alanine aminotransferase (ALT) more than 5x the upper limit of normal or creatinine greater than 3x the upper limit of normal

• Evidence of chronic disease or physical stigmata of severe malnutrition (i.e., loss of muscle mass or subcutaneous tissue, edema, or skin or hair findings consistent with severe malnutrition)