Clinical trial NCT01636895: Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria
Official title: An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregnancy Complications Parasitic
Keywords: malaria
pregnancy
prevention
treatment
molecular markers
Lead sponsor: Malaria Consortium, UK
Sponsor class: NETWORK
Collaborators: name: Department for International Development, United Kingdom
name: London School of Hygiene and Tropical Medicine
name: University of Nigeria, Enugu Campus
First posted: 2012-07-10
Enrollment: 600
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women
timeFrame: 15 months
Secondary outcomes:
measure: To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women
timeFrame: 15 months
measure: To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women
timeFrame: 15 months
Other outcomes:
Locations:
city: Enugu,
country: Nigeria
facility: Damboa Hospital Borno state and Park Lane hospital Enugu state
state: borno State and Enugu state
Study officials:
affiliation: London School of hygeine and tropical medicine
name: Daniel Chandramohan, PHD
role: STUDY_CHAIR
affiliation: College of Medicine, University of Nigeria , Enugu Campus
name: Elvis N Shu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaria Consortium
name: Ebenezer S Baba, MBBS, MPH
role: STUDY_DIRECTOR
References: