OR1: Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

Sponsor

Malaria Consortium, UK (Other)

Overall Status

Unknown status

CT.gov ID

NCT01636895

Collaborator

Department for International Development, United Kingdom (Other), London School of Hygiene and Tropical Medicine (Other), University of Nigeria, Enugu Campus (Other)

600

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study has two components: component A is a cohort study to determine the in vivo efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component B is a cross sectional study of women delivering at the study hospitals to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance. Results of component A and B studies will be used to model the relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Complications Parasitic	Drug: Efficacy of suphladoxine/pyrimethamine as IPTp Drug: Efficacy of suphladoxine/pyrimethamine as IPTp	Phase 4

Detailed Description

Study sites will include different levels of transmission and social factors affecting ANC attendance Damboa hospital in Borno state has a catchment area with pop of 231,573 with a semi arid climate and where malaria is mesoendemic. The expected number of patients is 15-25 per week for new bookings Park Lane hospital serves a semiurban population. Malaria transmission is holoendemic and stable. 1400 women attend ANC services per month Women will receive SP-IPTp according to National guidelines and will be followed for 42 days to assess the therapeutic efficacy in parasitaemic women and to assess the ability to remain parasite free. PCR will be used to determine reinfection from recrudescence

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Nov 1, 2012

Anticipated Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SP-IPTp efficacy Efficacy of suphladoxine/pyrimethamine as IPTp	Drug: Efficacy of suphladoxine/pyrimethamine as IPTp 3 tablets (single dose)given twice during pregnancy one month apart after quickening Other Names: Fansidar Drug: Efficacy of suphladoxine/pyrimethamine as IPTp 2 courses of 3 tablets of 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine)administered (at least 1 month apart) as DOTs to pregnant mother after quickening Other Names: Fansidar

Arm

Intervention/Treatment

Experimental: SP-IPTp efficacy

Efficacy of suphladoxine/pyrimethamine as IPTp

Drug: Efficacy of suphladoxine/pyrimethamine as IPTp

3 tablets (single dose)given twice during pregnancy one month apart after quickening

Other Names:

Fansidar

Drug: Efficacy of suphladoxine/pyrimethamine as IPTp

2 courses of 3 tablets of 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine)administered (at least 1 month apart) as DOTs to pregnant mother after quickening

Other Names:

Fansidar

Outcome Measures

Primary Outcome Measures

To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women [15 months]
PCR corrected Adequate parasitological clearance by day 42

Secondary Outcome Measures

To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women [15 months]
PCR uncorrected parasitological clearance by day 42
To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women [15 months]
Prevalence of molecular markers of SP resistance at enrolment

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

gestational age 16-30 weeks
Axillary temperature ,37.5 Degrees
informed consent

Exclusion Criteria:

gravida > 2
previous inclusion in this study
history of hypersensitivity to SP or components of SP
Use of IPTp with SP during this pregnancy
history of taking other antimalarials in the past month
Known HIV infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damboa Hospital Borno state and Park Lane hospital Enugu state	Enugu,	borno State and Enugu state	Nigeria

Sponsors and Collaborators

Malaria Consortium, UK
Department for International Development, United Kingdom
London School of Hygiene and Tropical Medicine
University of Nigeria, Enugu Campus

Investigators

Study Chair: Daniel Chandramohan, PHD, London School of hygeine and tropical medicine
Principal Investigator: Elvis N Shu, PHD, College of Medicine, University of Nigeria , Enugu Campus
Study Director: Ebenezer S Baba, MBBS, MPH, Malaria Consortium