Status:
COMPLETED
Chloroquine Alone or in Combination for Malaria in Children in Malawi
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Plasmodium Falciparum Infection
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
Brief 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 child...
Detailed Description
Combination therapy is becoming the mainstay of malaria treatment. In general, the goal of combination therapy is to treat resistant infections successfully and to prevent the emergence and spread of ...
Eligibility Criteria
Inclusion
- 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:
- fever at the time of evaluation (axillary temperature greater than or equal to 37.5 degrees Celsius by digital thermometer)
- report of fever within the last two days
- clinically profound anemia (conjunctival or palmar pallor)
- headache
- body aches
- abdominal pain
- decreased intake of food or fluids
- 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
- Signs of severe malaria: One or more of the following:
- hemoglobin less than or equal to 5 g/dL
- 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 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)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT00379821
Start Date
February 1 2007
End Date
September 1 2012
Last Update
August 11 2014
Active Locations (1)
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1
Blantyre Malaria Project - Ndirande Health Centre
Blantyre, Blantyre, Malawi