To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia
Information source: Menzies School of Health Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Falciparum Malaria; Vivax Malaria
Intervention: Chloroquine and sulphadoxine-pyrimethamine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Menzies School of Health Research Official(s) and/or principal investigator(s):
Emiliana Tjitre, PhD, Principal Investigator, Affiliation: National Institute of Health Research and Development (NIHRD), Indonesia
Summary
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.
Clinical Details
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.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: • 42 day cure rate; corrected for reinfection by PCR genotyping.• Overall Cure Rate at Day 42
Secondary outcome: • 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)
Eligibility
Minimum age: 12 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female patients at least one 1year of age and weighing more than 10kg.
- -Microscopic confirmation of P. falciparum and /or P. vivax infection (any
parasitaemia).
- -Fever (axillary temperature >37. 5oC) or history of fever in the last 48 hours.
- -Able to participate in the trial and comply with the clinical trial protocol
- -Written informed consent to participate in trial; verbal consent in presence of
literate witness is required for illiterate patients, and written consent from
parents/guardian for children below age of consent
Exclusion Criteria:
- Pregnancy or lactation
- -Inability to tolerate oral treatment
- -Signs/symptoms indicative of severe/complicated malaria or warning signs
requiring parenteral treatment
- -Known hypersensitivity or allergy to artemisinin derivatives
- -Serious underlying disease (cardiac, renal or hepatic)
- -Parasitaemia >4%
Locations and Contacts
SP9 & SP12 Public Health- Malaria control clinics, Timika, Papua, Indonesia
Additional Information
Starting date: April 2004
Last updated: September 7, 2005
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