Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Role of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria And Its Effects in Pregnancy
Brief Summary: Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women and children are the most vulnerable population. Malaria in pregnancy increases the risks of abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia are recommended.

HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV infected persons, and CTX prophylaxis significantly improves birth outcomes in immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we aim to establish the safety and efficacy of daily CTX in preventing malaria infection during pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This information is urgently needed to assist to issue guidelines on IPT in pregnancy.


Options:
A: Intervention Type: DRUG; Name: Sulfadoxine-Pyrimethamine (Fansidar); Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: ITNs; Assigned to Arm(s): N/A
B: Arm Label: Daily TS + Monthly DP pregnancy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS) | Arm Label: Daily TS + DP Placebo pregnancy; Type: PLACEBO_COMPARATOR; Interventions: Drug: Monthly placebo + daily trimethoprim/sulfamethoxazole (TS) | Intervention Type: DRUG; Name: Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS); Assigned to Arm(s): Daily TS + Monthly DP pregnancy | Intervention Type: DRUG; Name: Monthly placebo + daily trimethoprim/sulfamethoxazole (TS); Assigned to Arm(s): Daily TS + DP Placebo pregnancy
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Cotrimoxazole | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sulfadoxine-pyrimethamine | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Cotrimoxazole | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sulfadoxine-pyrimethamine | Intervention Type: DRUG; Name: Cotrimoxazole; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: Sulfadoxine-pyrimethamine; Assigned to Arm(s): 2, 4
D: Arm Label: Mefloquine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mefloquine | Arm Label: Sulphadoxine-Pyrimethamine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sulphadoxine-Pyrimethamine | Intervention Type: DRUG; Name: Mefloquine; Assigned to Arm(s): Mefloquine | Intervention Type: DRUG; Name: Sulphadoxine-Pyrimethamine; Assigned to Arm(s): Sulphadoxine-Pyrimethamine

Answer: C