Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial
Abstract Background An estimated 300,000 babies are born with sickle cell anaemia (SCA) annually. Affected children have chronic ill health and suffer premature death. Febrile illnesses such as malaria commonly precipitate acute crises in children with SCA. Thus, chemoprophylaxis for malaria is an i...
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| Format: | Article |
| Language: | English |
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BMC
2023-04-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07274-4 |
| _version_ | 1797849932926812160 |
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| author | Thandile Nkosi-Gondwe Bjarne Robberstad Robert Opoka Dennis Kalibbala Joseph Rujumba Lufina Tsirizani Galileya Pamela Akun Winnie Nambatya John Ssenkusu Feiko TerKuile Kamija Phiri Richard Idro |
| author_facet | Thandile Nkosi-Gondwe Bjarne Robberstad Robert Opoka Dennis Kalibbala Joseph Rujumba Lufina Tsirizani Galileya Pamela Akun Winnie Nambatya John Ssenkusu Feiko TerKuile Kamija Phiri Richard Idro |
| author_sort | Thandile Nkosi-Gondwe |
| collection | DOAJ |
| description | Abstract Background An estimated 300,000 babies are born with sickle cell anaemia (SCA) annually. Affected children have chronic ill health and suffer premature death. Febrile illnesses such as malaria commonly precipitate acute crises in children with SCA. Thus, chemoprophylaxis for malaria is an important preventive strategy, but current regimes are either sub-optimally effective (e.g. monthly sulphadoxine-pyrimethamine, SP) or difficult to adhere to (e.g. daily proguanil). We propose dihydroartemisinin-piperaquine (DP) as the agent with the most potential to be used across Africa. Methods This will be a randomised, double-blind, parallel-group superiority trial of weekly single-day courses of DP compared to monthly single-day courses of SP in children with SCA. The study will be conducted in eastern (Uganda) and southern (Malawi) Africa using randomisation stratified by body weight and study centre. Participants will be randomised using an allocation of 1:1 to DP or SP. We will investigate the efficacy, safety, acceptability and uptake and cost-effectiveness of malaria chemoprevention with weekly courses of DP vs monthly SP in 548 to 824 children with SCA followed up for 12–18 months. We will also assess toxicity from cumulative DP dosing and the development of resistance. Participant recruitment commenced on 30 April 2021; follow-up is ongoing. Discussion At the end of this study, findings will be used to inform regional health policy. This manuscript is prepared from protocol version 2.1 dated 1 January 2022. Trial registration The trial was registered at ClinicalTrials.gov, NCT04844099 . Registered on 08 April 2021. |
| first_indexed | 2024-04-09T18:52:09Z |
| format | Article |
| id | doaj.art-df58b96f3ad242e3be37dcec8d1b8ab5 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T18:52:09Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-df58b96f3ad242e3be37dcec8d1b8ab52023-04-09T11:26:07ZengBMCTrials1745-62152023-04-0124111410.1186/s13063-023-07274-4Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trialThandile Nkosi-Gondwe0Bjarne Robberstad1Robert Opoka2Dennis Kalibbala3Joseph Rujumba4Lufina Tsirizani Galileya5Pamela Akun6Winnie Nambatya7John Ssenkusu8Feiko TerKuile9Kamija Phiri10Richard Idro11Training and Research Unit of ExcellenceUniversity of BergenMakerere University College of Health SciencesGlobal Health UgandaMakerere University College of Health SciencesTraining and Research Unit of ExcellenceMakerere University College of Health SciencesMakerere University College of Health SciencesMakerere University College of Health SciencesLiverpool School of Tropical MedicineTraining and Research Unit of ExcellenceMakerere University College of Health SciencesAbstract Background An estimated 300,000 babies are born with sickle cell anaemia (SCA) annually. Affected children have chronic ill health and suffer premature death. Febrile illnesses such as malaria commonly precipitate acute crises in children with SCA. Thus, chemoprophylaxis for malaria is an important preventive strategy, but current regimes are either sub-optimally effective (e.g. monthly sulphadoxine-pyrimethamine, SP) or difficult to adhere to (e.g. daily proguanil). We propose dihydroartemisinin-piperaquine (DP) as the agent with the most potential to be used across Africa. Methods This will be a randomised, double-blind, parallel-group superiority trial of weekly single-day courses of DP compared to monthly single-day courses of SP in children with SCA. The study will be conducted in eastern (Uganda) and southern (Malawi) Africa using randomisation stratified by body weight and study centre. Participants will be randomised using an allocation of 1:1 to DP or SP. We will investigate the efficacy, safety, acceptability and uptake and cost-effectiveness of malaria chemoprevention with weekly courses of DP vs monthly SP in 548 to 824 children with SCA followed up for 12–18 months. We will also assess toxicity from cumulative DP dosing and the development of resistance. Participant recruitment commenced on 30 April 2021; follow-up is ongoing. Discussion At the end of this study, findings will be used to inform regional health policy. This manuscript is prepared from protocol version 2.1 dated 1 January 2022. Trial registration The trial was registered at ClinicalTrials.gov, NCT04844099 . Registered on 08 April 2021.https://doi.org/10.1186/s13063-023-07274-4MalariaSickle cell anaemiaChemopreventionMortalityDihydroartemisinin-piperaquineSulphadoxine-pyrimethamine |
| spellingShingle | Thandile Nkosi-Gondwe Bjarne Robberstad Robert Opoka Dennis Kalibbala Joseph Rujumba Lufina Tsirizani Galileya Pamela Akun Winnie Nambatya John Ssenkusu Feiko TerKuile Kamija Phiri Richard Idro Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial Trials Malaria Sickle cell anaemia Chemoprevention Mortality Dihydroartemisinin-piperaquine Sulphadoxine-pyrimethamine |
| title | Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial |
| title_full | Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial |
| title_fullStr | Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial |
| title_full_unstemmed | Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial |
| title_short | Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial |
| title_sort | dihydroartemisinin piperaquine or sulphadoxine pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern africa chemcha a protocol for a multi centre two arm double blind randomised placebo controlled superiority trial |
| topic | Malaria Sickle cell anaemia Chemoprevention Mortality Dihydroartemisinin-piperaquine Sulphadoxine-pyrimethamine |
| url | https://doi.org/10.1186/s13063-023-07274-4 |
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