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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Falciparum Malaria Vivax Malaria

Keywords

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Falciparum Vivax Papua Chloroquine Sulphadoxine-pyrimethamine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Chloroquine and sulphadoxine-pyrimethamine

Intervention Type DRUG

Eligibility Criteria

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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%

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Emiliana Tjitre, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Locations

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SP9 & SP12 Public Health- Malaria control clinics

Timika, Special Region of Papua, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Wellcome Trust ME028458MES

Identifier Type: -

Identifier Source: secondary_id

Timika_FP_VP