Malaria in Early Life Study

Summary

The purpose of this study is to assess the effectiveness of different malaria control strategies in the first year of life. The effectiveness of delivering an intermittent screening and treatment programme with dihydroartemisinin-piperaquine (DHP), linked to local immunization programmes, will be compared to the current practice of passive case detection of malaria. This study has two objectives: 1. To assess the effectiveness of intermittent screening and treatment with dihydroartemisinin-piperaquine (DHP) administered at 2, 3, 4 and 9 months of age compared with the current practice of passive detection and treatment for malaria in an area with high drug resistance levels to both P. falciparum and P. vivax. 2. To evaluate the safety, efficacy and population pharmacokinetics of DHP in children under 1 year of age.

Timeline

Start

2014-07-21

Primary completion

2016-03-31

Completion

2017-05-17

Outcome

Missed primary endpoint

paper adjusted incidence rate ratio [aIRR] 1.77 [95% CI, 0.62-5.01]; p = 0.280 PMID 35672703 ↗

paper adjusted prevalence ratio (aPR) = 0.92 (95% CI, 0.70-1.21), p = 0.55 PMID 35672703 ↗

Publications

• Poespoprodjo JR, Hafiidhaturrahmah, Sariyanti N, Indrawanti R, McLean ARD, Simpson JA, Kenangalem E, Burdam FH, Noviyanti R, Trianty L, Fadhilah C, Soenarto Y, Price RN. Intermittent screening and treatment for malaria complementary to routine immunisation in the first year of life in Papua, Indonesia: a cluster randomised superiority trial. BMC Med. 2022 Jun 8;20(1):190. doi: 10.1186/s12916-022-02394-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARTENIMOL	Small molecule	40 mg	—
Subject	piperaquine	Small molecule	320 mg	—

Indications