The purpose of this research study is to find out how well chloroquine works as a drug to treat malaria in children, compared to the standard malaria treatment (Fansidar) in Malawi.

Condition	Intervention	Phase
Malaria	Drug: chloroquine phosphate  Drug: sulfadoxine/pyrimethamine	Phase IV

Further Study Details: 

Expected Total Enrollment:  210

This is a 6-month, single center, randomized, open-label study of 210 peri-urban children 6 to 12 years old with uncomplicated malaria in Blantyre, Malawi to assess and compare the anti-malarial efficacy of oral chloroquine versus sulfadoxine-pyrimethamine (SP) (standard therapy used in Malawi). Additionally, this study also aims to assess the effect of the re-introduction of chloroquine on the molecular markers associated with chloroquine resistance. It will also gather data to support a longitudinal study of chloroquine alone and in combination with other anti-malarial drugs. The subject participation will be for 28 days consisting of day 1 (initial visit) and follow-up visits on days 2, 3, 7, 14, 21 and 28 in accordance with the standard WHO protocol. Because chloroquine has not been used to treat malaria in Malawi for over a decade, special safety precautions will be taken at the beginning of the study where the initial 30 subjects will remain under continuous observation until resolution of the infection to monitor response to therapy. A Safety Monitoring Committee will be created and an Independent Safety Monitor will be appointed to review safety data on site as the study progresses. Malaria is a devastating disease in Africa, with high incidence rate of mortality and morbidity; therefore, unless and until an effective vaccine against malaria is developed, case management with prompt and effective therapy will remain the mainstay of malarial control. This study follows the observation that since chloroquine was discontinued in 1992, it has been speculated that years of reliance on other antimalarials might lead to the reemergence of chloroquine-sensitive P. falciparum and permit the reintroduction of this safe and affordable drug. If removing a drug from use were to result in disappearance of parasites resistant to that drug, the possibility of rotating the limited number of safe, effective and affordable antimalarial drugs could be considered.

Ages Eligible for Study:  6 Months   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Patients aged >= 6 months to 12 years presenting to Ndirande Health Centre with signs or symptoms consistent with malaria including but not limited to one or more of the following

• fever at the time of evaluation (axillary temperature 37.5�C by digital thermometer)
• report of fever within the last two days
• profound anemia (conjunctival or palmar pallor)
• headache
• body aches
• abdominal pain
• decreased intake of food or fluids
• weakness Positive malaria smear for P. falciparum mono-infection Willingness to be admitted to the hospital for 3 days Informed consent

Exclusion Criteria:

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

• hemoglobin 5 g/dl
• parasitemia 10%
• prostration
• respiratory distress
• bleeding
• recent seizures, coma or obtundation (Blantyre coma score 5)
• inability to drink
• persistent vomiting Known allergy or history of adverse reaction to SP, sulfa drugs or chloroquine Chronic medication with an antifolate drug

Please refer to this study by ClinicalTrials.gov identifier  NCT00125489

Christopher Plowe      (410) 706-5328 

Maryland
      University of Maryland School of Medicine, Baltimore,  Maryland,  21201,  United States; Recruiting
      University of Maryland School of Medicine, Baltimore,  Maryland,  21201,  United States; Recruiting
Malawi
      Blantyre Malaria Project, Blantyre,  Malawi; Recruiting

Study ID Numbers:  05-0012
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125489
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02