To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia
Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/- doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28 days for vivax malaria.
The study hypothesis was that current recommended antimalarial protocols were no longer effective.
Drug: Chloroquine and sulphadoxine-pyrimethamine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||To Evaluate the Efficacy of Chloroquine and SP for Acute Uncomplicated P. Falciparum and the Efficacy of Chloroquine for Acute Uncomplicated P. Vivax in the Timika Region of Papua, Indonesia.|
- • 42 day cure rate; corrected for reinfection by PCR genotyping.
- • Overall Cure Rate at Day 42
- • Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.
- • Parasite reduction. Parasite reduction will be calculated at Days 1, 2 and 3 after initiation of trial treatment as percentage of parasites/uL compared to parasite density before the first dose of treatment.
- • Proportion of patients with a negative slide at Days 1, 2 and 3
- • Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.
- • Early Treatment Failure (ETF)
- • Late Treatment Failure (LTF)
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||September 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157859
|SP9 & SP12 Public Health- Malaria control clinics|
|Timika, Papua, Indonesia|
|Principal Investigator:||Emiliana Tjitre, PhD||National Institute of Health Research and Development (NIHRD), Indonesia|