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Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda (SP IPTp)

Primary Purpose

Intermittent Preventive Treatment, Placental Malaria

Status
Withdrawn
Phase
Phase 4
Locations
Uganda
Study Type
Interventional
Intervention
Sulfadoxine-pyrimethamine
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intermittent Preventive Treatment focused on measuring Malaria, Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Infectious Disease Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SP

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 17, 2010
Last Updated
March 3, 2015
Sponsor
University of California, San Francisco
Collaborators
Centers for Disease Control and Prevention, Uganda Malaria Surveillance Project
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1. Study Identification

Unique Protocol Identification Number
NCT01184911
Brief Title
Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
Acronym
SP IPTp
Official Title
Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Research plan changed; no longer conducting clinical trial.
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
Centers for Disease Control and Prevention, Uganda Malaria Surveillance Project

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Preventive Treatment, Placental Malaria
Keywords
Malaria, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SP
Arm Type
Experimental
Arm Description
Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-pyrimethamine
Other Intervention Name(s)
Kamsidar, Fansidar
Intervention Description
Sulfadoxine-pyrimethamine tablets, once
Primary Outcome Measure Information:
Title
Parasite clearance
Description
Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP
Time Frame
42 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Ades, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Filler, MD, DTM&H
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moses Kamya, MBChB, MMed, MPH, PhD
Organizational Affiliation
Uganda Malaria Surveillance Project
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Disease Research Center
City
Tororo
Country
Uganda

12. IPD Sharing Statement

Links:
URL
http://www.muucsf.org/umsp/about_umsp.html
Description
UMSP website

Learn more about this trial

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

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