Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru
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Purpose
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 who have a diagnosis of uncomplicated malaria due to P. falciparum. Patients will receive a treatment regimen consisting of mefloquine (25 mg/kg per day for two days) and artesunate (12 mg/kg per day for three days). Patients will be divided into two groups: one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves. Clinical and parasitologic response will be monitored for a follow-up period of 28 days. The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P. falciparum malaria treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria Falciparum |
Drug: mefloquine plus artesunate |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Evaluation of the Efficacy and Effectiveness of Combined Therapy With Mefloquine and Artesunate for Uncomplicated Malaria Treatment in the Loreto Region (Amazon Basin), Peru |
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| Peru | |
| Loreto Healthcare Facility | |
| Iquitos, Loreto, Peru | |
| Principal Investigator: | Alexandre Macedo de Oliveira, MD, MSc | Centers for Disease Control and Prevention |
| Principal Investigator: | Wilmer Marquiño Quezada, MD | National Institute of Health, Peru |
More Information
No publications provided
| Responsible Party: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00164216 History of Changes |
| Other Study ID Numbers: | CDC-NCID-4476 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United States: Federal Government Peru: Ministry of Health |
Keywords provided by Centers for Disease Control and Prevention:
|
malaria combination therapy mefloquine |
artesunate Peru malaria, uncomplicated |
Additional relevant MeSH terms:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Mefloquine Artesunate Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Amebicides |
ClinicalTrials.gov processed this record on May 19, 2013