Malaria Clinical Trial
— DHP+PQOfficial title:
Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia
Verified date | August 2008 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission.The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in Sumatra, Indonesia.
Status | Completed |
Enrollment | 374 |
Est. completion date | October 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years and older |
Eligibility |
Inclusion Criteria: - age = 4 years old - parasite count = 1,000 asexual parasites/µL - normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA) - hemoglobin level = 8 gr/dL as measured by Hemoque® apparatus; - have the ability to return for 42-day-follow up and - willingness to sign the informed-consent form. Exclusion Criteria: - are infected with other r plasmodium species - have only gametocytes of P. falciparum; - are pregnant - measured by positive result on HCG urine test and/or breastfeeding women - present signs of pitting edema on both legs as a sign of malnutrition - have complicated or severe malaria, other chronic diseases or history of drug allergies. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Indonesia | Hanura Primary Health Center | Lampung | Sumatra |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of sexual stages of P.falciparum | Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification. | 42 days post treatment | Yes |
Secondary | Clearance of asexual stages P.falciparum | Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification. | 42 days post treatment | Yes |
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