Status:
COMPLETED
CQSP in Malawi: Chloroquine and Sulfadoxine-pyrimethamine Efficacy for the Treatment of Malaria in Malawi
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Plasmodium Falciparum Malaria
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
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 in Malawi. In preparation for a longer s...
Detailed Description
This study follows the observation that chloroquine-resistant malaria may have returned to Malawi, 10 years after its use was eliminated. There is growing consensus that combination chemotherapy shoul...
Eligibility Criteria
Inclusion
- 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
- Parasite density of 2,000-200,000/microliter or \< 10%
- Willingness to remain at the Health Centre under continuous observation until the resolution of the infection
- Parental consent for each participant, and child assent for children older than 5 years
Exclusion
- Signs of severe malaria: One or more of the following:
- hemoglobin \< 5 g/dl
- parasitemia \> 10%
- prostration \* as indicated by inability to drink or breastfeed
- respiratory distress (deep Kussmaul respirations)
- bleeding
- recent seizures\*, coma\* or mental obtundation\* (Blantyre coma score less than 5)
- persistent vomiting\*
- Presence of a severe disease
- Presence of a febrile condition caused by diseases other than malaria
- Known allergy or history of adverse reaction to sulfadoxine/pyrimethamine (SP), sulfa drugs or chloroquine
- Chronic medication with an antifolate drug
- Enrollment in this clinical study in the past 28 days \*Each of these symptoms or signs is considered a "danger sign."
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00125489
Start Date
May 1 2005
End Date
December 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
Blantyre Malaria Project
Blantyre, Malawi