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Completed

NCT Number: NCT00157859

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

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Key information

Conditions

Falciparum Malaria Infections Malaria Malaria, Falciparum Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases Vivax Malaria

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SP9 & SP12 Public Health- Malaria control clinics

Timika, Special Region of Papua, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Chloroquine and sulphadoxine-pyrimethamine

Drug

Primary outcomes

  1. • 42 day cure rate; corrected for reinfection by PCR genotyping.

  2. • Overall Cure Rate at Day 42

Secondary outcomes

  1. • Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.

  2. • 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.

  3. • Proportion of patients with a negative slide at Days 1, 2 and 3

  4. • Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.

  5. • Early Treatment Failure (ETF)

  6. • Late Treatment Failure (LTF)

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

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

Registry information

Official study 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.

Important dates

Study start
2004
Study completion
2004
First posted
Sep 12, 2005
Registry last updated
Sep 12, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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