Trial reportPloS one2010
A randomised trial to compare the safety, tolerability and efficacy of three drug combinations for intermittent preventive treatment in children.
Trial report in PloS one, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00561899 (Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia), which is not on this map. Cited by 40 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia
Who cites it
40 citing papers in PubMed, 9 syntheses or guidelines pooled it, 68 citations in OpenAlex.
- Systematic Review and Meta-Analysis of Seasonal Malaria Chemoprevention.The American journal of tropical medicine and hygiene · 2024Pooled it
- Post-discharge malaria chemoprevention in children admitted with severe anaemia in malaria-endemic settings in Africa: a systematic review and individual patient data meta-analysis of randomised controlled trials.The Lancet. Global health · 2024Pooled it
- Intermittent preventive treatment for malaria in infants.The Cochrane database of systematic reviews · 2021Pooled it
- Intermittent preventive treatment for malaria in infants.The Cochrane database of systematic reviews · 2019Pooled it
- Safety, tolerability, and efficacy of repeated doses of dihydroartemisinin-piperaquine for prevention and treatment of malaria: a systematic review and meta-analysis.The Lancet. Infectious diseases · 2017Pooled it
- Efficacy and safety of intermittent preventive treatment for malaria in schoolchildren: a systematic review.Malaria journal · 2015Pooled it
- Mass drug administration for malaria.The Cochrane database of systematic reviews · 2013Pooled it
- Intermittent preventive treatment for malaria in children living in areas with seasonal transmission.The Cochrane database of systematic reviews · 2012Pooled it
- A systematic review and meta-analysis of the efficacy and safety of intermittent preventive treatment of malaria in children (IPTc).PloS one · 2011Pooled it
- Randomized Field Trial to Assess the Safety and Efficacy of Dihydroartemisinin-Piperaquine for Seasonal Malaria Chemoprevention in School-Aged Children in Bandiagara, Mali.The Journal of infectious diseases · 2024Trial
- Malaria Chemoprevention in the Postdischarge Management of Severe Anemia.The New England journal of medicine · 2020Trial
- Intermittent preventive treatment with dihydroartemisinin-piperaquine and risk of malaria following cessation in young Ugandan children: a double-blind, randomised, controlled trial.The Lancet. Infectious diseases · 2019Trial
- Optimal dosing of dihydroartemisinin-piperaquine for seasonal malaria chemoprevention in young children.Nature communications · 2019Trial
- Efficacy and safety of primaquine and methylene blue for prevention of Plasmodium falciparum transmission in Mali: a phase 2, single-blind, randomised controlled trial.The Lancet. Infectious diseases · 2018Trial
- Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso.Antimicrobial agents and chemotherapy · 2015Trial
- Selection of drug resistance-mediating Plasmodium falciparum genetic polymorphisms by seasonal malaria chemoprevention in Burkina Faso.Antimicrobial agents and chemotherapy · 2014Trial
- Trial
- Two strategies for the delivery of IPTc in an area of seasonal malaria transmission in the Gambia: a randomised controlled trial.PLoS medicine · 2011Trial
- Article
- Extending seasonal malaria chemoprevention to older children: a non-inferiority randomized controlled trial of Dihydroartemisinin-piperaquine as a policy alternative in Mali.The Lancet regional health. Africa · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundResults from trials of intermittent preventive treatment (IPT) in infants and children have shown that IPT provides significant protection against clinical malaria. Sulfadoxine-pyrimethamine (SP) given alone or in combination with other drugs has been used for most IPT programmes. However, SP resistance is increasing in many parts of Africa. Thus, we have investigated whether SP plus AQ, SP plus piperaquine (PQ) and dihydroartemisinin (DHA) plus PQ might be equally safe and effective when used for IPT in children in an area of seasonal transmission.
methodsDuring the 2007 malaria transmission season, 1008 Gambian children were individually randomized to receive SP plus amodiaquine (AQ), SP plus piperaquine (PQ) or dihydroartemisinin (DHA) plus PQ at monthly intervals on three occasions during the peak malaria transmission season. To determine the risk of side effects following drug administration, participants in each treatment group were visited at home three days after the start of each round of drug administration and a side effects questionnaire completed. To help establish whether adverse events were drug related, the same questionnaire was administered to 286 age matched control children recruited from adjacent villages. Morbidity was monitored throughout the malaria transmission season and study children were seen at the end of the malaria transmission season.
resultsAll three treatment regimens showed good safety profiles. No severe adverse event related to IPT was reported. The most frequent adverse events reported were coughing, diarrhoea, vomiting, abdominal pain and loss of appetite. Cough was present in 15.2%, 15.4% and 18.7% of study subjects who received SP plus AQ, DHA plus PQ or SP plus PQ respectively, compared to 19.2% in a control group. The incidence of malaria in the DHA plus PQ, SP plus AQ and SP plus PQ groups were 0.10 cases per child year (95% CI: 0.05, 0.22), 0.06 (95% CI: 0.022, 0.16) and 0.06 (95% CI: 0.02, 0.15) respectively. The incidence of malaria in the control group was 0.79 cases per child year (0.58, 1.08).
conclusionAll the three regimens of IPT in children were safe and highly efficacious
trial registrationClinicalTrials.gov NCT00561899.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.