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Clinical Trials/NCT01184911
NCT01184911
Withdrawn
Phase 4

Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

University of California, San Francisco1 site in 1 countryOctober 2010
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ConditionsIntermittent Preventive TreatmentPlacental Malaria
InterventionsSulfadoxine-pyrimethamine
DrugsSulfadoxine-pyrimethamine

Overview

Phase
Phase 4
Intervention
Sulfadoxine-pyrimethamine
Conditions
Intermittent Preventive Treatment
Sponsor
University of California, San Francisco
Locations
1
Primary Endpoint
Parasite clearance
Status
Withdrawn
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
September 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •16-26 weeks gestation based on LMP or ultrasound or fundal height
  • •Axillary temperature \<37.5 degrees C
  • •Informed consent
  • •HIV status known and negative
  • •Blood smear positive for falciparum malaria

Exclusion Criteria

  • •History of hypersensitivity reaction to SP or components of SP
  • •Axillary temperature ≥37.5 degrees C
  • •History of receipt of antimalarials or antibiotics with antimalarial activity\* in the past month
  • •Residence \> 30 km from the ANC clinic or unwillingness to return for follow-up visits
  • •Hemoglobin level \< 5 gm/dL
  • •These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.

Arms & Interventions

SP

Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria

Intervention: Sulfadoxine-pyrimethamine

Outcomes

Primary Outcomes

Parasite clearance

Time Frame: 42 days

Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP

Study Sites (1)

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