NCT00331708

Brief Summary

The main purpose of this study is to compare the drug levels of artesunate and sulfadoxine-pyrimethamine found in pregnant women with malaria to those drug levels found in non-pregnant women from other studies. In addition the efficacy and safety of the study drugs will be determined for pregnant women and their babies.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

May 30, 2006

Last Update Submit

October 25, 2016

Conditions

Malaria

Keywords

MalariaEfficacyPharmacokineticGametocyteMolecular markersSulfadoxine-pyrimethamineArtesunateArtemisinin

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic parameters by measurement of whole blood levels of sulfadoxine and pyrimethamine and plasma levels of artesunate and its active metabolite dihydroartemisinin to determine Cmax, Tmax, AUC, half life, volume of distribution and clearance

  • Correlation of treatment outcome with pharmacokinetic parameters and pregnancy status.

Secondary Outcomes (5)

  • Association of gametocyte carriage with pregnancy status

  • Correlation of frequency of DHFR mutations at codons 108, 51, 59 (164) and DHPS mutations at codons 436, 437, 540 and 581 in maternal and placental samples with treatment outcome

  • Birth outcomes in terms of congenital abnormalities, spontaneous abortions, still births and neonatal deaths, gestational age and birth weight, placental weight, newborn head circumference

  • Risk of harm by describing adverse events and their causality assessments, neurodevelopmental assessment of infants and changes in full blood count (or haemoglobin), glucose, bilirubin, creatinine, urea and ALT

  • Capacity building by describing the training and development of study teams and their subsequent skills attained.

Study Arms (1)

Artesunate plus sulphadoxine-pyrimethamine

EXPERIMENTAL
Drug: Artesunate plus sulfadoxine-pyrimethamine

Interventions

Artesunate plus sulfadoxine-pyrimethamineDRUG
Artesunate plus sulphadoxine-pyrimethamine

Eligibility Criteria

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

You may qualify if:

  • Pregnant female, older than 18 years, \> 35kg.
  • Gestational age \> 16 weeks (fundal height \> 16cm) and below 36 weeks gestation.
  • Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 250 000 asexual parasites/ul blood with axillary temperature of greater than or equal to 37.5°C or history of fever (defined as fever within the previous 24 hours).
  • Documented written informed consent.
  • Lives close enough to the study site for reliable follow up and is willing to attend ANC and follow-up visits regularly.
  • Is willing to stop taking folate for 7 days if applicable.

You may not qualify if:

  • Has received anti-malarial treatment in the past 7 days.
  • Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated) or other danger signs (Appendix 2).
  • Known hepatic or renal impairment
  • Has received chloramphenicol or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
  • History of G6PD deficiency.
  • Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole, or other artemisinin derivatives e.g. co-artemether).
  • Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
  • Imminent delivery expected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ndlavela Health Centre

Ndlavela, Maputo, Mozambique

Location

MeSH Terms

Conditions

Malaria

Interventions

Artesunatefanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Karen I Barnes, MBChB

    University of Cape Town

    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 INVESTIGATOR
PI Title
Professor, Clinical Pharmacology

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

MO(1)