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

Primary Purpose

Falciparum Malaria, Vivax Malaria

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Chloroquine and sulphadoxine-pyrimethamine
Sponsored by
Menzies School of Health Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Falciparum Malaria focused on measuring Falciparum, Vivax, Papua, Chloroquine, Sulphadoxine-pyrimethamine

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

  • SP9 & SP12 Public Health- Malaria control clinics

Outcomes

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)

Full Information

First Posted
September 7, 2005
Last Updated
September 7, 2005
Sponsor
Menzies School of Health Research
Collaborators
Wellcome Trust, National Health and Medical Research Council, Australia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT00157859
Brief Title
To Evaluate Current Efficacy of Antimalarials Used in Timika, Papua, Indonesia
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 Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falciparum Malaria, Vivax Malaria
Keywords
Falciparum, Vivax, Papua, Chloroquine, Sulphadoxine-pyrimethamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Chloroquine and sulphadoxine-pyrimethamine
Primary Outcome Measure Information:
Title
• 42 day cure rate; corrected for reinfection by PCR genotyping.
Title
• Overall Cure Rate at Day 42
Secondary Outcome Measure Information:
Title
• Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.
Title
• 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.
Title
• Proportion of patients with a negative slide at Days 1, 2 and 3
Title
• Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.
Title
• Early Treatment Failure (ETF)
Title
• Late Treatment Failure (LTF)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliana Tjitre, PhD
Organizational Affiliation
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
SP9 & SP12 Public Health- Malaria control clinics
City
Timika
State/Province
Papua
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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