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dc.contributor.authorGiri, Abhishek
dc.contributor.authorKarkey, Abhilasha
dc.contributor.authorDongol, Sabina
dc.contributor.authorArjyal, Amit
dc.contributor.authorMaharjan, Archana
dc.contributor.authorVeeraraghavan, Balaji
dc.contributor.authorPaudyal, Buddhi
dc.contributor.authorDolecek, Christiane
dc.contributor.authorGajurel, Damodar
dc.contributor.authorPhuong, Dung Nguyen Thi
dc.contributor.authorThanh, Duy Pham
dc.contributor.authorQamar, Farah
dc.contributor.authorKang, Gagandeep
dc.contributor.authorHien, Ho Van
dc.contributor.authorJohn, Jacob
dc.contributor.authorLawson, Katrina
dc.contributor.authorWolbers, Marcel
dc.contributor.authorHossain, Md Shabab
dc.contributor.authorSharifuzzaman, M
dc.contributor.authorLuangasanatip, Nantasit
dc.contributor.authorMaharjan, Nhukesh
dc.contributor.authorOlliaro, Piero
dc.contributor.authorRupali, Priscilla
dc.contributor.authorShakya, Ronas
dc.contributor.authorShakoor, Sadia
dc.contributor.authorRijal, Samita
dc.contributor.authorQureshi, Sonia
dc.contributor.authorBaker, Stephen
dc.contributor.authorJoshi, Subi
dc.contributor.authorAhmed, Tahmeed
dc.contributor.authorDarton, Thomas
dc.contributor.authorBao, Tran Nguyen
dc.contributor.authorLubell, Yoel
dc.contributor.authorKestelyn, Evelyne
dc.contributor.authorThwaites, Guy
dc.contributor.authorParry, Christopher M
dc.contributor.authorBasnyat, Buddha
dc.description.abstractBackground: Typhoid and paratyphoid fever (enteric fever) is a common cause of non-specific febrile infection in adults and children presenting to health care facilities in low resource settings such as the South Asia.  A 7-day course of a single oral antimicrobial such as ciprofloxacin, cefixime, or azithromycin is commonly used for its treatment. Increasing antimicrobial resistance threatens the effectiveness of these treatment choices. We hypothesize that combined treatment with azithromycin (active mainly intracellularly) and cefixime (active mainly extracellularly) will be a better option for the treatment of clinically suspected and culture-confirmed typhoid fever in South Asia. Methods: This is a phase IV, international multi-center, multi-country, comparative participant-and observer-blind, 1:1 randomised clinical trial. Patients with suspected uncomplicated typhoid fever will be randomized to one of the two interventions: Arm A: azithromycin 20mg/kg/day oral dose once daily (maximum 1gm/day) and cefixime 20mg/kg/day oral dose in two divided doses (maximum 400mg bd) for 7 days, Arm B: azithromycin 20mg/kg/day oral dose once daily (max 1gm/day) for 7 days AND cefixime-matched placebo for 7 days. We will recruit 1500 patients across sites in Bangladesh, India, Nepal, and Pakistan. We will assess whether treatment outcomes are better with the combination after one week of treatment and at one- and three-months follow-up. Discussion: Combined treatment may limit the emergence of resistance if one of the components is active against resistant sub-populations not covered by the other antimicrobial activity. If the combined treatment is better than the single antimicrobial treatment, this will be an important result for patients across South Asia and other typhoid endemic areas. registration: NCT04349826 (16/04/2020).
dc.publisherF1000 Research Ltd
dc.rightsAttribution 4.0 International
dc.sourcenlmid: 101696457
dc.sourceessn: 2398-502X
dc.subjectSouth Asia
dc.subjectEnteric Fever
dc.titleAzithromycin and cefixime combination versus azithromycin alone for the out-patient treatment of clinically suspected or confirmed uncomplicated typhoid fever in South Asia: a randomised controlled trial protocol.
prism.publicationNameWellcome Open Res
dc.contributor.orcidGiri, Abhishek [0000-0003-0670-1433]
dc.contributor.orcidMaharjan, Archana [0000-0003-3144-802X]
dc.contributor.orcidPaudyal, Buddhi [0000-0002-5119-4082]
dc.contributor.orcidKang, Gagandeep [0000-0002-3656-564X]
dc.contributor.orcidHien, Ho Van [0000-0002-3609-8455]
dc.contributor.orcidLawson, Katrina [0000-0001-6180-9995]
dc.contributor.orcidHossain, Md Shabab [0000-0002-2862-8639]
dc.contributor.orcidLuangasanatip, Nantasit [0000-0001-8501-6092]
dc.contributor.orcidShakya, Ronas [0000-0002-7148-4028]
dc.contributor.orcidBaker, Stephen [0000-0003-1308-5755]
dc.contributor.orcidDarton, Thomas [0000-0003-2209-9956]
dc.contributor.orcidLubell, Yoel [0000-0002-0237-1070]
dc.contributor.orcidKestelyn, Evelyne [0000-0002-5728-0918]
dc.contributor.orcidThwaites, Guy [0000-0002-2858-2087]
dc.contributor.orcidParry, Christopher M [0000-0001-7563-7282]
dc.contributor.orcidBasnyat, Buddha [0000-0002-1125-2743]
pubs.funder-project-idMedical Research Council (MR/T005033/1)

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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International