MedTrace Logo

Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan

NCT01178021 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 593

Last updated 2019-01-15

No results posted yet for this study

Summary

This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs.

Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine

Conditions

  • Vivax Malaria

Interventions

DRUG

Chloroquine

Chloroquine 10 mg/kg on day 0 \& 1 and 5mg/kg on day 2

DRUG

Chloroquine/Primaquine

Chloroquine 10 mg/kg on day 0 \& 1 and 5mg/kg on day 2 Primaquine (if given) 0.25mg/kg/day for 14 days

Sponsors & Collaborators

  • National Malaria and Leishmaniasis Control Program, Afghanistan

    collaborator OTHER_GOV

  • Mahidol University

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Ghulam Rahim Awab, MD · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Afghanistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01178021 on ClinicalTrials.gov