Status:
COMPLETED
Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
National Institute of Health, Peru
Conditions:
Malaria Falciparum
Eligibility:
All Genders
1+ years
Brief Summary
This is a study of the efficacy and effectiveness of combination therapy for malaria due to P. falciparum in the Loreto Department, Iquitos, Peru. The investigators will enroll subjects ≥ 1 year-old w...
Eligibility Criteria
Inclusion
- Age \> 1 year
- Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause
- Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear
- An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old)
- Willingness to come to the health facility for the following 28 days
Exclusion
- Signs or symptoms of severe malaria
- Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition)
- History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin
- Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00164216
Start Date
March 1 2005
End Date
March 1 2008
Last Update
September 11 2012
Active Locations (1)
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1
Loreto Healthcare Facility
Iquitos, Loreto, Peru