NCT04816461: SMC-RST

Boosting the Impact of SMC Through Simultaneous Screening and Treatment of Roommates

Completed Phase 4 Last updated 22 January 2025

What this trial tests

Phase 4 trial testing Amodiaquine Sulfadoxine-Pyrimethamin administration in Malaria in 526 participants. Completed in 30 June 2023.

Timeline

7 July 2021

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Institut de Recherche en Sciences de la Sante, Burkina Faso
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	526
Start date	7 July 2021
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across Burkina Faso

Drugs / interventions tested

• Amodiaquine Sulfadoxine-Pyrimethamin administration — full drug profile →
• Dihydroartemisinin-Piperaquine
• Standard HRP2-RDT

Conditions studied

• Malaria — all drugs for Malaria →
• Malaria Prophylaxis — all drugs for Malaria Prophylaxis →
• Mass Testing and Treatment — all drugs for Mass Testing and Treatment →

Sponsor

Institut de Recherche en Sciences de la Sante, Burkina Faso — full company profile →

Who can join

Eligibility, any sex, with Malaria or Malaria Prophylaxis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Malaria represents a major public health concern in sub-Sahara Africa. Seasonal malaria chemoprevention (SMC) is one of the largest preventive measures. It consists to administer Amodiaquine+Sulfadoxine-Pyrimethamine to children aged 3-59 months on a monthly basis during the peak malaria transmission season. Despite its implementation, the burden of malaria is still very high in children under five years old in Burkina Faso. This raises questions about other hidden factors that can negatively affect the effectiveness of SMC intervention. Huge effort aiming at preventing human-vector contact were deployed such as the large-scale distribution of insecticide treated bed nets. Healthy humans are only infected via mosquitos if there are parasites reservoir around. Yet, there is no strategy aiming at protecting healthy humans from parasites reservoir. Under these circumstances, multiples humans sharing the same habitat could continually entertain the transmission cycle despite adequate existing measures. This would obviously jeopardize the expected impact of the SMC and the global effort to control the disease. In such context, we postulate that screening and treating malaria SMC-children's roommates could greatly improve the impact of SMC intervention and reduce malaria transmission in endemic settings.

The goal of our study is to improve the impact of SMC intervention in terms of reducing malaria morbidity and mortality in children under five years. Primary objectives include assessing whether SMC + children's roommates screening and treatment with Dihydro-artemisinin-piperaquine (DHAPPQ) is more effective than current routine implementation of SMC alone as well as the assessment of the tolerance and safety of AQSP and DHAPPQ. Secondary objectives include the assessment of the impact of the new strategy on the circulating parasite population in terms of selection of resistant strains and the assessment of determinants such as adherence and acceptability of the strategy.

Methodology: The study will be carried out in the Nanoro health district catchment area in Burkina Faso. This will be a randomized superiority trial. The unit of randomization will be the household and all eligible children from a household will be allocated to the same study group to avoid confusion. Households with 3 - 59 months old children will be assigned to either (i) control group (SMC alone) or (ii) intervention (SMC+ roommates screening with standard HRP2-RDT and treatment if positive) . The sample size will be 526 isolated households per arm, i.e. around 1,052 children under CPS coverage and 1,315 roommates expected. They will be followed-up for 24 months to fully cover two consecutive malaria transmission seasons and then two SMC cycles. Children will be actively followed-up during the malaria transmission seasons while in the dry seasons the followed-up will be passive.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Boosting the impact of seasonal malaria chemoprevention (SMC) through simultaneous screening and treatment of household members of children receiving SMC in Burkina Faso: a protocol for a randomized open label trial.
   Sondo P, Tahita MC, Ilboudo H, Rouamba T, et al · · 2022 · cited 8× · PMID 35081964 · DOI 10.1186/s13690-022-00800-x
2. Trend of N86Y and Y184F Mutations in Pfmdr1 Gene in Children Under Seasonal Malaria Chemoprevention Coverage in Nanoro, Burkina Faso.
   Millogo KS, Kaboré B, Sondo P, Compaoré EW, et al · · 2024 · cited 2× · PMID 39356425 · DOI 10.1007/s11686-024-00923-x
3. Malaria and malnutrition in children under the Seasonal Malaria Chemoprevention (SMC) coverage in the health district of Nanoro, Burkina Faso.
   Compaore EW, Sondo P, Kabore B, Rouamba T, et al · · 2026 · PMID 41729835 · DOI 10.1371/journal.pone.0342237
4. Undetected <i>Plasmodium malariae</i> and <i>P. ovale</i> infections in HRP2 RDT-positive children with uncomplicated malaria in Nanoro, Burkina Faso.
   Kouevi AFC, Bayala IMC, Sondo P, Kaboré B, et al · · 2025 · PMID 40693034 · DOI 10.5281/zenodo.15965746
5. Seasonal malaria chemoprevention and mutations in <i>Pfdhfr</i> and <i>Pfdhps</i> genes in children in the health district of Nanoro, Burkina Faso.
   Millogo KS, Zabré A, Sondo P, Kaboré B, et al · · 2025 · PMID 40124705 · DOI 10.5281/zenodo.15039792