Evidence map›Paper›PMID 18493312›Full record

Trial reportPloS one2008

A multi-center randomised controlled trial of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever in children and adults in Vietnam.

Christiane Dolecek, Thi Phi La Tran, Ngoc Rang Nguyen, Thi Phuong Le, Vinh Ha, Quoc Tuan Phung, Cong Du Doan, Thi Be Bay Nguyen, Thanh Long Duong, Bich Ha Luong and 20 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
17.3field-weighted citation impact, top 1% 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
NCT04349826 phase4completednot on this mapstarted 2021, after this paper: background citation

Azithromycin 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

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2021 to 2025Enrolled2,150ConditionsTyphoid FeverArmsAzithromycin, Cefixime, Placebo
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.

  1. Fluoroquinolones for treating typhoid and paratyphoid fever (enteric fever).The Cochrane database of systematic reviews · 2011
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  17. Frontiers in cellular and infection microbiology · 2024
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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

30 authors at 6 institutions in 3 countries.

Christiane DolecekOxford University Clinical Research Unit, The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam. cdolecek@oucru.org
Thi Phi La Tran
Ngoc Rang Nguyen
Thi Phuong Le
Vinh Ha
Quoc Tuan Phung
Cong Du Doan
Thi Be Bay Nguyen
Thanh Long Duong
Bich Ha Luong
Trung Binh Nguyen
Thi Anh Hong Nguyen
Ngoc Dung Pham
Ngoc Lanh Mai
Van Be Bay Phan
Anh Ho Vo
Van Minh Hoang Nguyen
Thu Thi Nga Tran
Thuy Chau Tran
Constance Schultsz
Sarah J Dunstan
Kasia Stepniewska
James Ian Campbell
Song Diep To
Buddha Basnyat
Van Vinh Chau Nguyen
Van Sach Nguyen
Tran Chinh Nguyen
Tinh Hien Tran
Jeremy Farrar
An Giang University · VNHospital for Tropical Diseases · VNOxford University Clinical Research Unit · VNDong Thap Hospital · VNJohn Radcliffe Hospital · GBPatan Hospital · NP

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundDrug resistant typhoid fever is a major clinical problem globally. Many of the first line antibiotics, including the older generation fluoroquinolones, ciprofloxacin and ofloxacin, are failing.

objectivesWe performed a randomised controlled trial to compare the efficacy and safety of gatifloxacin (10 mg/kg/day) versus azithromycin (20 mg/kg/day) as a once daily oral dose for 7 days for the treatment of uncomplicated typhoid fever in children and adults in Vietnam.

methodsAn open-label multi-centre randomised trial with pre-specified per protocol analysis and intention to treat analysis was conducted. The primary outcome was fever clearance time, the secondary outcome was overall treatment failure (clinical or microbiological failure, development of typhoid fever-related complications, relapse or faecal carriage of S. typhi). PRINCIPAL

findingsWe enrolled 358 children and adults with suspected typhoid fever. There was no death in the study. 287 patients had blood culture confirmed typhoid fever, 145 patients received gatifloxacin and 142 patients received azithromycin. The median FCT was 106 hours in both treatment arms (95% Confidence Interval [CI]; 94-118 hours for gatifloxacin versus 88-112 hours for azithromycin), (logrank test p = 0.984, HR [95% CI] = 1.0 [0.80-1.26]). Overall treatment failure occurred in 13/145 (9%) patients in the gatifloxacin group and 13/140 (9.3%) patients in the azithromycin group, (logrank test p = 0.854, HR [95% CI] = 0.93 [0.43-2.0]). 96% (254/263) of the Salmonella enterica serovar Typhi isolates were resistant to nalidixic acid and 58% (153/263) were multidrug resistant.

conclusionsBoth antibiotics showed an excellent efficacy and safety profile. Both gatifloxacin and azithromycin can be recommended for the treatment of typhoid fever particularly in regions with high rates of multidrug and nalidixic acid resistance. The cost of a 7-day treatment course of gatifloxacin is approximately one third of the cost of azithromycin in Vietnam.

trial registrationControlled-Trials.com ISRCTN67946944.

Indexed as

AdultAnti-Bacterial AgentsAzithromycinChildFluoroquinolonesGatifloxacinHumansMicrobial Sensitivity TestsSalmonellaSpecies SpecificityTyphoid FeverAnti-Bacterial AgentsAzithromycinFluoroquinolonesGatifloxacin

Identifiers

PMID18493312
PMCPMC2374894
OpenAlexW2010565659

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.