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Trial record 29 of 68 for:    Diseases | ( Map: Mozambique )

Pharmacokinetics, Efficacy, Gametocyte Carriage, Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00380146
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : October 26, 2016
Global Fund
Medical Research Council, South Africa
Information provided by (Responsible Party):
Professor Karen I Barnes, University of Cape Town

Brief Summary:
The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine found when given to pregnant women for the prevention of malaria to those found in pregnant women given the same drug with artesunate for the treatment of malaria, and also with those drug levels found in non-pregnant women in other malaria treatment studies.

Condition or disease Intervention/treatment Phase
Malaria Drug: sulfadoxine-pyrimethamine Not Applicable

Detailed Description:
Pregnancy increases the risk of malaria progression and complications with up to a 10-fold increase in the malaria case fatality rate in areas of low transmission. Sulfadoxine-pyrimethamine (SP) is used widely in Africa for the systematic intermittent presumptive, or preventive, treatment (IPTp) during the second and third trimester of pregnancy and a national program of IPTp with SP has been implemented recently in Mozambique. There is evidence that the kinetics of several other antimalarial drugs are altered in pregnancy to the extent that doses are not adequate in pregnancy, however no published study has included a pharmacokinetic component to confirm that standard doses of SP are optimal in this vulnerable patient group. This study therefore creates the opportunity to study whether the pharmacokinetic properties of SP are altered by physiological changes that occur during pregnancy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label in Vivo Drug Study to Evaluate the Pharmacokinetics, Therapeutic Efficacy, Gametocyte Carriage and Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment (SP IPT) in Pregnant Women
Study Start Date : September 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: SP plus artesunate
SP (Fansidar®, Roche South Africa) at a dose of 25/1.25mg/kg of sulfadoxine/pyrimethamine respectively on day 0 only, and artesunate (Arsumax®, Sanofi-Aventis, South Africa) at a dose of 4mg/kg on days 0, 1, and 2
Drug: sulfadoxine-pyrimethamine

Primary Outcome Measures :
  1. Pharmacokinetic parameters by measurement of whole blood levels of sulfadoxine and pyrimethamine and plasma levels of artesunate to determine Cmax, Tmax, AUC, half life, volume of distribution and clearance [ Time Frame: 0 hours (pre treatment) and repeated on day 0 or 1 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours, and days 2, 3, 7, 14, 21, 28 and 42 ]

Secondary Outcome Measures :
  1. Correlation of treatment outcome and gametocyte carriage with pharmacokinetic parameters and pregnancy status [ Time Frame: 0 hours (pre treatment) and repeated on day 0 or 1 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours, and days 2, 3, 7, 14, 21, 28 and 42 , and time of birth outcome ]
  2. Correlation of frequency of DHFR mutations at codons 436, 437, 540 and 581 in maternal and placental samples with treatment outcomes [ Time Frame: Day 42 (or day of withdrawal) ]
  3. Birth outcomes in terms of major congenital abnormalities, spontaneous abortions, still births and neonatal deaths, gestational age and birth weight, placental weight, newborn head circumference, arm circumference and neurological development [ Time Frame: Day of birth outcome ]
  4. Risk of harm by describing all adverse events and their causality assessments and changes in full blood count, glucose, bilirubin, creatinine, urea and ALT [ Time Frame: Days 3, 7, 14, 21, 28 and every 2 weeks thereafter until birth (for a minimum of 42 days) or withdrawal visit ]
  5. Capacity building by describing the training and development of study teams and their subsequent skills attained [ Time Frame: Duration of trial ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pregnant female, older than 18 years, > 35kg.
  • Gestational age > 16 weeks (fundal height > 16cm) and below 36 weeks gestation.
  • Documented informed consent.
  • Lives close enough to the study site for reliable follow up and is willing to attend ANC and follow-up visits regularly.

Exclusion Criteria:

  • Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia
  • Has received anti-malarial treatment in the past 7 days and/or sulfadoxine-pyrimethamine in the past 28 days.
  • Known hepatic or renal impairment
  • Has received chloramphenicol, cotrimoxazole 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).
  • 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.
  • Prior inclusion in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00380146

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Ndlavela Health Centre
Ndlavela, Maputo, Mozambique
Sponsors and Collaborators
Professor Karen I Barnes
Global Fund
Medical Research Council, South Africa
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Principal Investigator: Karen I Barnes, MBChB University of Cape Town

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Responsible Party: Professor Karen I Barnes, Professor, Clinical Pharmacology, University of Cape Town Identifier: NCT00380146     History of Changes
Other Study ID Numbers: SEACAT2.2
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Professor Karen I Barnes, University of Cape Town:
Intermittent presumptive treatment
Molecular markers

Additional relevant MeSH terms:
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Parasitic Diseases
Protozoan Infections
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents