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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


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)


Minimum age: 12 Months. Maximum age: N/A. Gender(s): Both.


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


- -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

Page last updated: August 23, 2015

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