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

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01184911

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), Uganda Malaria Surveillance Project (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Preventive Treatment Placental Malaria	Drug: Sulfadoxine-pyrimethamine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SP Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria	Drug: Sulfadoxine-pyrimethamine Sulfadoxine-pyrimethamine tablets, once Other Names: Kamsidar, Fansidar

Arm

Intervention/Treatment

Experimental: SP

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

Drug: Sulfadoxine-pyrimethamine

Sulfadoxine-pyrimethamine tablets, once

Other Names:

Kamsidar, Fansidar

Outcome Measures

Primary Outcome Measures

Parasite clearance [42 days]
Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Infectious Disease Research Center	Tororo		Uganda

Sponsors and Collaborators

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

Investigators

Principal Investigator: Veronica Ades, MD, MPH, University of California, San Francisco
Principal Investigator: Scott Filler, MD, DTM&H, Centers for Disease Control and Prevention
Principal Investigator: Moses Kamya, MBChB, MMed, MPH, PhD, Uganda Malaria Surveillance Project