Safety of Daily Co-Trimoxazole in Pregnancy in an Area of Changing Malaria Epidemiology: A Phase 3b Randomized Controlled Clinical Trial

Christine Manyando; Eric M. Njunju; David Mwakazanga; Gershom Chongwe; Rhoda Mkandawire; Davies Champo; Modest Mulenga; Maaike De Crop; Yves Claeys; Raffaella M. Ravinetto; Chantal van Overmeir; Umberto D’ Alessandro; Jean-Pierre Van geertruyden

doi:10.1371/journal.pone.0096017

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Open Access

Peer-reviewed

Research Article

Safety of Daily Co-Trimoxazole in Pregnancy in an Area of Changing Malaria Epidemiology: A Phase 3b Randomized Controlled Clinical Trial

Christine Manyando ,

* E-mail: cmanyando@yahoo.com

Affiliations Tropical Diseases Research Centre, Ndola, Zambia, International Health Unit, University of Antwerp, Antwerp, Belgium
⨯
Eric M. Njunju,

Affiliations Tropical Diseases Research Centre, Ndola, Zambia, International Health Unit, University of Antwerp, Antwerp, Belgium
⨯
David Mwakazanga,

Affiliation Tropical Diseases Research Centre, Ndola, Zambia
⨯
Gershom Chongwe,

Affiliation Tropical Diseases Research Centre, Ndola, Zambia
⨯
Rhoda Mkandawire,

Affiliation Choma District Health Management Team, Choma, Zambia
⨯
Davies Champo,

Affiliation Tropical Diseases Research Centre, Ndola, Zambia
⨯
Modest Mulenga,

Affiliation Tropical Diseases Research Centre, Ndola, Zambia
⨯
Maaike De Crop,

Affiliation Institute of Tropical Medicine, Antwerp, Belgium
⨯
Yves Claeys,

Affiliation Institute of Tropical Medicine, Antwerp, Belgium
⨯
Raffaella M. Ravinetto,

Affiliations Institute of Tropical Medicine, Antwerp, Belgium, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
⨯
Chantal van Overmeir,

Affiliation Institute of Tropical Medicine, Antwerp, Belgium
⨯
Umberto D’ Alessandro,

Affiliations Institute of Tropical Medicine, Antwerp, Belgium, Medical Research Council, Fajara, The Gambia
⨯
Jean-Pierre Van geertruyden

Affiliation International Health Unit, University of Antwerp, Antwerp, Belgium
⨯

Safety of Daily Co-Trimoxazole in Pregnancy in an Area of Changing Malaria Epidemiology: A Phase 3b Randomized Controlled Clinical Trial

Christine Manyando,
Eric M. Njunju,
David Mwakazanga,
Gershom Chongwe,
Rhoda Mkandawire,
Davies Champo,
Modest Mulenga,
Maaike De Crop,
Yves Claeys,
Raffaella M. Ravinetto

Published: May 15, 2014
https://doi.org/10.1371/journal.pone.0096017

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Correction to the Methods section

Posted by RaffaellaRavinetto on 26 May 2014 at 07:02 GMT

On behalf of the first author and of all the other co-authors, I wish to clarify that the Methods section in our paper needs to be corrected. The sub-section "Decision to Stop the Trial in Choma" makes reference to the contribution of a Data Safety Monitoring Board (DSMB), while no DSMB was in place for this study. A DSMB was set up, at a later stage, for a similar study carried out at another location with higher malaria prevalence.

Raffaella M. Ravinetto

No competing interests declared.

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Safety of Daily Co-Trimoxazole in Pregnancy in an Area of Changing Malaria Epidemiology: A Phase 3b Randomized Controlled Clinical Trial

Safety of Daily Co-Trimoxazole in Pregnancy in an Area of Changing Malaria Epidemiology: A Phase 3b Randomized Controlled Clinical Trial

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Correction to the Methods section

Posted by RaffaellaRavinetto on 26 May 2014 at 07:02 GMT