NCT00811096

Brief Summary

Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to justify an IND and formal phase II evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

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

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

2 months

First QC Date

December 17, 2008

Last Update Submit

November 30, 2012

Conditions

Malaria, Vivax

Keywords

Malaria, Vivax/*drug therapyTinidazole/pharmacology/*therapeutic useRecurrencePlasmodium vivax/*drug effects

Outcome Measures

Primary Outcomes (1)

  • Cure is defined as absence of malaria infection on thick/thin malaria smears up to and on day 63 after initial clearance of parasitemia. Subjects will be followed to day 90 to rule out delayed presentation of malaria (as opposed to cure).

    63 days

Secondary Outcomes (1)

  • Recurrence (relapse, recrudescence or re-infection) of Plasmodium vivax between blood stage clearance and 90 days.

    90 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL
Drug: Tinidazole

Comparator Arm

ACTIVE COMPARATOR

Comparator Arm

Drug: chloroquine

Interventions

TinidazoleDRUG

2gms, p.o. q.d. for 5 days

Treatment Arm
chloroquineDRUG
Comparator Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male and non-pregnant female volunteers that can communicate in the Burmese or Karen language.
  • Age: Between 18 and 65 years (inclusive).
  • Acute, symptomatic, blood smear positive diagnosis of Plasmodium vivax mono-infection.
  • Ability to comprehend and comply with the requirements of the protocol.
  • Willing to provide written informed consent.
  • Willing to abstain from alcohol (EtOH) use during initial treatment and for 72 hours thereafter.
  • Sexually active females must test negative on urine pregnancy test and must be counseled on an effective method of avoiding pregnancy (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or Depo-Provera®), be surgically sterile, be post-menopause for at least one year, or be monogamous with a sterile sexual partner for at least 15 days prior to dosing with study product and at least 72 hours after their last dose of test drug.

You may not qualify if:

  • Subjects positive for G6PD deficiency.
  • Pregnant women (clinically or by positive urine β-HCG) and nursing mothers.
  • Concomitant use of metronidazole, albendazole or mebendazole.
  • Significant health problems, including, but not limited to significant, cardiac, renal or liver disease or lab abnormalities and those subjects in whom it is suspected that they will not abstain from alcohol use during treatment and for the subsequent 3 days.
  • Mixed malaria infection on admission determined by malaria smear and/or any positive HRP2 antigen testing.
  • A previous history of significant intolerance or hypersensitivity to the study drug tinidazole or to chloroquine or primaquine. (nausea alone from previous primaquine use will not be an excluding factor unless subject was unable to complete a primaquine course due to this discomfort.)
  • Subjects that have received transfusions within the previous 30 days.
  • Presenting hematocrit \<25%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Research Unit, 68/30 Ban Toong Road, P.O. Box 46

Mae Sot, Changwat Tak, Thailand

Location

Related Publications (1)

  • Macareo L, Lwin KM, Cheah PY, Yuentrakul P, Miller RS, Nosten F. Triangular test design to evaluate tinidazole in the prevention of Plasmodium vivax relapse. Malar J. 2013 May 29;12:173. doi: 10.1186/1475-2875-12-173.

    PMID: 23718705DERIVED

MeSH Terms

Conditions

Malaria, VivaxMalariaRecurrence

Interventions

TinidazoleChloroquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Francois Nosten, MD

    Malaria Research Unit, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

TH(1)