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

Menzies School of Health Research

Status: Completed

Conditions: Vivax Malaria; Falciparum Malaria

Treatments: Drug: Chloroquine and sulphadoxine-pyrimethamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00157859

Timika_FP_VP

Wellcome Trust ME028458MES

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ months old

Volunteers: No 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%

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)