Evidence map›Paper›PMID 17593957›Full record

Trial reportPloS one2007

An open randomized comparison of gatifloxacin versus cefixime for the treatment of uncomplicated enteric fever.

Anil Pandit, Amit Arjyal, Jeremy N Day, Buddhi Paudyal, Sabina Dangol, Mark D Zimmerman, Bharat Yadav, Kasia Stepniewska, James I Campbell, Christiane Dolecek and 2 more

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

Trial report in PloS one, 2007. 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 41 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 4 pooled it
2.9field-weighted citation impact, top 9% 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

41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
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  3. Fluoroquinolones for treating typhoid and paratyphoid fever (enteric fever).The Cochrane database of systematic reviews · 2011
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  20. Antimicrobial Resistance inMicrobiology insights · 2021
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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

12 authors at 4 institutions in 3 countries.

Anil PanditPatan Hospital, Lagankhel, Lalitpur, Nepal.
Amit Arjyal
Jeremy N Day
Buddhi Paudyal
Sabina Dangol
Mark D Zimmerman
Bharat Yadav
Kasia Stepniewska
James I Campbell
Christiane Dolecek
Jeremy J Farrar
Buddha Basnyat
Patan Hospital · NPHospital for Tropical Diseases · VNNuffield Orthopaedic Centre · GBOxford University Clinical Research Unit · VN

Funding

Wellcome Trust
6 · The paper itself

Abstract

objectiveTo assess the efficacy of gatifloxacin versus cefixime in the treatment of uncomplicated culture positive enteric fever.

designA randomized, open-label, active control trial with two parallel arms.

settingEmergency Room and Outpatient Clinics in Patan Hospital, Lagankhel, Lalitpur, Nepal.

participantsPatients with clinically diagnosed uncomplicated enteric fever meeting the inclusion criteria.

interventionsPatients were allocated to receive one of two drugs, Gatifloxacin or Cefixime. The dosages used were Gatifloxacin 10 mg/kg, given once daily for 7 days, or Cefixime 20 mg/kg/day given in two divided doses for 7 days. OUTCOME MEASURES: The primary outcome measure was fever clearance time. The secondary outcome measure was overall treatment failure (acute treatment failure and relapse).

resultsRandomization was carried out in 390 patients before enrollment was suspended on the advice of the independent data safety monitoring board due to significant differences in both primary and secondary outcome measures in the two arms and the attainment of a priori defined endpoints. Median (95% confidence interval) fever clearance times were 92 hours (84-114 hours) for gatifloxacin recipients and 138 hours (105-164 hours) for cefixime-treated patients (Hazard Ratio[95%CI] = 2.171 [1.545-3.051], p<0.0001). 19 out of 70 (27%) patients who completed the 7 day trial had acute clinical failure in the cefixime group as compared to 1 out of 88 patients (1%) in gatifloxacin group(Odds Ratio [95%CI] = 0.031 [0.004 - 0.237], p<0.001). Overall treatment failure patients (relapsed patients plus acute treatment failure patients plus death) numbered 29. They were determined to be (95% confidence interval) 37.6 % (27.14%-50.2%) in the cefixime group and 3.5% (2.2%-11.5%) in the gatifloxacin group (HR[95%CI] = 0.084 [0.025-0.280], p<0.0001). There was one death in the cefixime group.

conclusionsBased on this study, gatifloxacin is a better treatment for uncomplicated enteric fever as compared to cefixime.

trial registrationCurrent Controlled Trials ISRCTN75784880.

Indexed as

AdolescentAdultAnti-Bacterial AgentsAnti-Infective AgentsAntitubercular AgentsCefiximeChildChild, PreschoolFemaleFluoroquinolonesGatifloxacinHumansMaleMicrobial Sensitivity TestsMiddle AgedPrognosisAnti-Bacterial AgentsAnti-Infective AgentsAntitubercular AgentsCefiximeFluoroquinolonesGatifloxacin

Identifiers

PMID17593957
PMCPMC1891439
OpenAlexW2052573224

What OpenQuestion holds

Textmetadata
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.