Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria (OR1)

Malaria Consortium, UK

Status and phase: Unknown; Phase 4

Conditions: Pregnancy Complications Parasitic

Treatments: Drug: Efficacy of suphladoxine/pyrimethamine as IPTp

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01636895

SuNMaP-OR1

Details and patient eligibility

About

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.

Full 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

Enrollment: 600 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

SP-IPTp efficacy

Experimental group

Description:

Efficacy of suphladoxine/pyrimethamine as IPTp

Treatment:

Drug: Efficacy of suphladoxine/pyrimethamine as IPTp

Drug: Efficacy of suphladoxine/pyrimethamine as IPTp