Clinical trial NCT00157859: 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
Overall status: COMPLETED
Phase: NA
Conditions: Falciparum Malaria
Vivax Malaria
Keywords: Falciparum
Vivax
Papua
Chloroquine
Sulphadoxine-pyrimethamine
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Health and Medical Research Council, Australia
name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
First posted: 2005-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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%

Primary outcomes:
measure: • 42 day cure rate; corrected for reinfection by PCR genotyping.
measure: • Overall Cure Rate at Day 42
Secondary outcomes:
measure: • Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point.
measure: • 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.
measure: • Proportion of patients with a negative slide at Days 1, 2 and 3
measure: • Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28.
measure: • Early Treatment Failure (ETF)
measure: • Late Treatment Failure (LTF)
Other outcomes:
Locations:
city: Timika
country: Indonesia
facility: SP9 & SP12 Public Health- Malaria control clinics
state: Papua
Study officials:
affiliation: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
name: Emiliana Tjitre, PhD
role: PRINCIPAL_INVESTIGATOR
References: