To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia

Sponsor

Menzies School of Health Research (Other)

Overall Status

Completed

CT.gov ID

NCT00157859

Collaborator

Wellcome Trust (Other), National Health and Medical Research Council, Australia (Other), National Institute of Health Research and Development, Ministry of Health Republic of Indonesia (Other)

150

Enrollment

Location

Duration (Months)

29.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Falciparum Malaria Vivax Malaria	Drug: Chloroquine and sulphadoxine-pyrimethamine	N/A

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Apr 1, 2004

Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

• 42 day cure rate; corrected for reinfection by PCR genotyping. []
• Overall Cure Rate at Day 42 []

Secondary Outcome Measures

• 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 Criteria

Criteria

Ages Eligible for Study:

12 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SP9 & SP12 Public Health- Malaria control clinics	Timika	Papua	Indonesia

Sponsors and Collaborators

Menzies School of Health Research
Wellcome Trust
National Health and Medical Research Council, Australia
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia