NCT00157859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

September 7, 2005

Conditions

Falciparum MalariaVivax Malaria

Keywords

FalciparumVivaxPapuaChloroquineSulphadoxine-pyrimethamine

Outcome Measures

Primary Outcomes (2)

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

  • • Overall Cure Rate at Day 42

Secondary Outcomes (6)

  • • 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)

  • +1 more secondary outcomes

Interventions

Chloroquine and sulphadoxine-pyrimethamineDRUG

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SP9 & SP12 Public Health- Malaria control clinics

Timika, Special Region of Papua, Indonesia

Location

MeSH Terms

Conditions

Malaria, FalciparumMalaria, Vivax

Interventions

Chloroquinefanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Emiliana Tjitre, PhD

    National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

April 1, 2004

Study Completion

September 1, 2004

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

ID(1)