NCT01546961

Brief Summary

For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body of evidence suggesting that pregnant women may require different doses of drugs, including antimalarials due to the physiological changes of pregnancy. It is important that any drug used in pregnant women it is given at the correct dose. The only way to evaluate this is by pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same evaluation in the same woman post-partum is required as a control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 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

June 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

5.4 years

First QC Date

March 1, 2012

Last Update Submit

January 7, 2019

Conditions

Vivax Malaria

Keywords

ChloroquineUncomplicated vivax malaria

Outcome Measures

Primary Outcomes (1)

  • Population Pharmacokinetics of Chloroquine

    Population pharmacokinetic parameters up to day 63 in pregnant women with uncomplicated P.vivax malaria, and in the same women post-partum with P.vivax or without P.vivax.

    63 days

Secondary Outcomes (4)

  • Relationship between pharmacokinetics and symptoms

    63 days

  • Efficacy of Chloroquine

    63 days

  • Reticulocyte counts

    63 days

  • Pregnancy outcomes

    63 days

Study Arms (1)

Chloroquine

EXPERIMENTAL

Chloroquine phosphate GPO® (Government Pharmaceutical Organization, Thailand) 250 mg (equivalent to chloroquine base 150 mg). Dosing will be at 0, 24, 48 hrs with 10 mg/kg on day 0 and day 1, and 5 mg/kg on day 2.

Drug: Chloroquine

Interventions

ChloroquineDRUG

Chloroquine phosphate GPO® (Government Pharmaceutical Organization, Thailand) 250 mg (equivalent to chloroquine base 150 mg). Dosing will be at 0, 24, 48 hrs with 10 mg/kg on day 0 and day 1, and 5 mg/kg on day 2.

Chloroquine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50 years
  • Gestational age (ultrasound confirmed) \> 13.0 weeks
  • Viable fetus as assessed by ultrasound scanning
  • Microscopically confirmed uncomplicated P.vivax malaria
  • Willingness and ability to comply with the study protocol for the duration of the trial
  • Written informed consent provided
  • No signs of labour

You may not qualify if:

  • Known hypersensitivity to chloroquine
  • Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1
  • Gastrointestinal dysfunction that could alter absorption or motility
  • History or known liver diseases or other chronic diseases (excluding thalassaemia \& G6PD deficiency)
  • Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study
  • Splenectomy
  • Hematocrit (HCT) \< 20% (based on field reading i.e. capillary sample)
  • Taking contraindicated medications
  • History of narcotic or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shoklo Malaria Research Unit

Tak, Mae Sot, 63110, Thailand

Location

MeSH Terms

Conditions

Malaria, Vivax

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Rose McGready, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

June 1, 2011

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

TH(1)