Evidence map›Paper›PMID 24282626›Full record

Trial reportPLoS neglected tropical diseases2013

Gatifloxacin versus ofloxacin for the treatment of uncomplicated enteric fever in Nepal: an open-label, randomized, controlled trial.

Samir Koirala, Buddha Basnyat, Amit Arjyal, Olita Shilpakar, Kabina Shrestha, Rishav Shrestha, Upendra Man Shrestha, Krishna Agrawal, Kanika Deshpande Koirala, Sudeep Dhoj Thapa and 10 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02773407 (Parallel Group, Double Blinded, 1), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
5.9field-weighted citation impact, top 5% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02773407 phase3completednot on this mapstarted 2016, after this paper: background citation

Parallel Group, Double Blinded, 1:1, Randomized Controlled Phase III Trial of Co-trimoxazole Versus Azithromycin for the Treatment of Undifferentiated Fever In Nepal

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2016 to 2019Enrolled330ConditionsUndifferentiated Febrile IllnessArmsAzithromycin, Co-trimoxazole
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
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  7. Article
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  11. Antimicrobial Resistance inMicrobiology insights · 2021
    Article
  12. Article
  13. The Invisible Burden: Diagnosing and Combatting Typhoid Fever in Asia and Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Undifferentiated febrile illness in Kathmandu, Nepal.The American journal of tropical medicine and hygiene · 2015
    Article
  19. Article
  20. Conducting randomized controlled trials for the treatment of enteric Fever.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 4 institutions in 3 countries.

Samir KoiralaOxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences, Patan Hospital, Patan, Nepal.
Buddha Basnyat
Amit Arjyal
Olita Shilpakar
Kabina Shrestha
Rishav Shrestha
Upendra Man Shrestha
Krishna Agrawal
Kanika Deshpande Koirala
Sudeep Dhoj Thapa
Abhilasha Karkey
Sabina Dongol
Abhishek Giri
Mila Shakya
Kamal Raj Pathak
James Campbell
Stephen Baker
Jeremy Farrar
Marcel Wolbers
Christiane Dolecek
Patan Academy of Health Sciences · NPPatan Hospital · NPUniversity of Oxford · GBLondon School of Hygiene & Tropical Medicine · GB

Funding

Wellcome Trust 089276/Z/09/ZWellcome Trust 100087
6 · The paper itself

Abstract

backgroundFluoroquinolones are the most commonly used group of antimicrobials for the treatment of enteric fever, but no direct comparison between two fluoroquinolones has been performed in a large randomised trial. An open-label randomized trial was conducted to investigate whether gatifloxacin is more effective than ofloxacin in the treatment of uncomplicated enteric fever caused by nalidixic acid-resistant Salmonella enterica serovars Typhi and Paratyphi A. METHODOLOGY AND PRINCIPAL

findingsAdults and children clinically diagnosed with uncomplicated enteric fever were enrolled in the study to receive gatifloxacin (10 mg/kg/day) in a single dose or ofloxacin (20 mg/kg/day) in two divided doses for 7 days. Patients were followed for six months. The primary outcome was treatment failure in patients infected with nalidixic acid resistant isolates. 627 patients with a median age of 17 (IQR 9-23) years were randomised. Of the 218 patients with culture confirmed enteric fever, 170 patients were infected with nalidixic acid-resistant isolates. In the ofloxacin group, 6 out of 83 patients had treatment failure compared to 5 out of 87 in the gatifloxacin group (hazard ratio [HR] of time to failure 0.81, 95% CI 0.25 to 2.65, p = 0.73). The median time to fever clearance was 4.70 days (IQR 2.98-5.90) in the ofloxacin group versus 3.31 days (IQR 2.29-4.75) in the gatifloxacin group (HR = 1.59, 95% CI 1.16 to 2.18, p = 0.004). The results in all blood culture-confirmed patients and all randomized patients were comparable.

conclusionGatifloxacin was not superior to ofloxacin in preventing failure, but use of gatifloxacin did result in more prompt fever clearance time compared to ofloxacin.

trial registrationISRCTN 63006567 (www.controlled-trials.com).

Indexed as

AdolescentAnti-Bacterial AgentsChildDrug Resistance, BacterialFemaleFluoroquinolonesGatifloxacinHumansMaleNepalOfloxacinSalmonella paratyphi ASalmonella typhiTreatment FailureTyphoid FeverYoung AdultAnti-Bacterial AgentsFluoroquinolonesGatifloxacinOfloxacin

Identifiers

PMID24282626
PMCPMC3837022
OpenAlexW1965964867

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.