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

Vivax Malaria Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157859
• Other study ID #: Timika_FP_VP
• Secondary ID: Wellcome Trust M
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: September 7, 2005
• Start date: April 2004
• Est. completion date: September 2004

Study information

• Verified date: September 2005
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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%

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falciparum Malaria
• Malaria
• Malaria, Falciparum
• Malaria, Vivax
• Vivax Malaria

Intervention

Drug:
• Chloroquine and sulphadoxine-pyrimethamine

Locations

Country	Name	City	State
Indonesia	SP9 & SP12 Public Health- Malaria control clinics	Timika	Papua

Sponsors (4)

Lead Sponsor	Collaborator
Menzies School of Health Research	National Health and Medical Research Council, Australia, National Institute of Health Research and Development (NIHRD), Indonesia, Wellcome Trust

Country where clinical trial is conducted

Indonesia, 

Outcome

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