The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract

• Status: Recruiting
• Trial end date: 2022-11-07
• Target enrollment: 0
• Participant gender: Female

Summary

Malaria in pregnancy has devastating consequences for mother and foetus. WHO recommends intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) for asymptomatic women, but high-level parasite resistance to SP threatens its efficacy. Dihydroartemisinin-piperaquine (DP) has the potential to replace SP for IPTp. However, the DP strategy has not been found to be superior to SP for reducing the incidence of low birthweight (LBW), small-for-gestational age (SGA), or preterm birth. This may be the result of sulphadoxine having antibacterial properties; it is derived from sulphonamide, which have been used for decades to treat curable STIs/RTIs. However, SP is unlikely to be curative of STIs/RTIs, nor highly effective against malaria parasites. Thus, combination treatment that contains a more efficacious antimalarial and a more efficacious anti-STI/RTI may produce better birth outcomes. The investigators will therefore determine whether combining SP with metronidazole (MTZ) or, separately, DP with MTZ can improve birth outcomes more than SP alone, potentially paving the way for integrated control strategies that will reduce the dual burden of malaria and curable STIs/RTIs.

This is an individually-randomized, 3-arm, partially-placebo controlled superiority trial comparing the efficacy, safety and tolerance of IPTp-SP versus IPTp-SP with MTZ, or IPTp-DP with MTZ to reduce adverse birth outcomes attributable to malaria and curable STIs/RTIs in 5,436 women in the Nchelenge District of Zambia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Fanasil, pyrimethamine drug combination; Metronidazole; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Pregnant women

• HIV-negative

• Gestational age from Week 16 and 0 Days to Week 28 and 0 Days (measured by sonography)

• Carrying a single viable pregnancy

• Resident in the study area

• Express willingness to adhere to scheduled and unscheduled study visit procedures, and deliver at a trial facility

Exclusion Criteria:

• HIV-positive

• Carrying multiple pregnancies (twins, etc.),

• Known cardiac ailment

• Severe malformations or nonviable pregnancy observed by ultrasound

• History of receiving IPTp-SP during the current pregnancy

• Known allergy or contraindication to any of the study drugs

• Unable to give consent

• Concurrently participating in any other trial, including prior enrolment in this trial.