Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

Pregnancy Complications Parasitic Clinical Trial

— OR1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01636895
• Other study ID #: SuNMaP-OR1
• Status: Recruiting
• Phase: Phase 4
• First received: July 5, 2012
• Last updated: August 21, 2012
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2012
• Source: Malaria Consortium, UK
• Contact: Dr Ebenezer Baba
• Is FDA regulated: No
• Health authority: Nigeria: The National Agency for Food and Drug Administration and Control
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Pregnancy Complications Parasitic

Intervention

Drug:
• Efficacy of suphladoxine/pyrimethamine as IPTp
3 tablets (single dose)given twice during pregnancy one month apart after quickening
• 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

Locations

Country	Name	City	State
Nigeria	Damboa Hospital Borno state and Park Lane hospital Enugu state	Enugu,	borno State and Enugu state

Sponsors (4)

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

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women	PCR corrected Adequate parasitological clearance by day 42	15 months	No
Secondary	To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women	PCR uncorrected parasitological clearance by day 42	15 months	Yes
Secondary	To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women	Prevalence of molecular markers of SP resistance at enrolment	15 months	No