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

Intermittent Preventive Treatment Clinical Trial

— SP IPTp  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01184911
• Other study ID #: CDC5972
• Status: Withdrawn
• Phase: Phase 4
• First received: August 17, 2010
• Last updated: March 3, 2015
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUganda: National Drug AuthorityUganda: National Council for Science and TechnologyUganda: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intermittent Preventive Treatment
• Malaria
• Placental Malaria

Intervention

Drug:
• Sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine tablets, once

Locations

Country	Name	City	State
Uganda	Infectious Disease Research Center	Tororo

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Centers for Disease Control and Prevention, Uganda Malaria Surveillance Project

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasite clearance	Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP	42 days	No