Evidence map›Paper›PMID 31952554›Full record

ArticleTrials2020

Shortening antibiotic duration in the treatment of acute cholangitis: rationale and study protocol for an open-label randomized controlled trial.

Kentaro Iwata, Asako Doi, Yuichiro Oba, Hiroo Matsuo, Kei Ebisawa, Manabu Nagata, Sho Nishimura, Kenichi Yoshimura, Atsuhiro Masuda, Hideyuki Shiomi and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 42% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
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

11 authors at 5 institutions in 1 country.

Kentaro IwataDivision of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan. kentaroiwata1969@gmail.com.ORCID http://orcid.org/0000-0003-2148-3016
Asako DoiDepartment of Infectious Diseases, Kobe City Medical Center General Hospital, Minatojimaminamimachi, Chuoku, Kobe, Hyogo, 650-0047, Japan.
Yuichiro ObaDepartment of General Medicine, Osaka General Medical Center, Bandaihigashi 3-1-56, Sumiyoshi, Osaka, 558-8558, Japan.
Hiroo MatsuoDepartment of Infectious Diseases, Hyogo Prefectural Amagasaki General Medical Center, Higashinanbacho 2-17-77, Amagasaki, Hyogo, 660-8550, Japan.
Kei EbisawaDivision of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan.
Manabu NagataDivision of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan.
Sho NishimuraDivision of Infectious Diseases Therapeutics, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan.
Kenichi YoshimuraInnovative Clinical Research Center (iCREK), Kanazawa University Hospital, 13-1 Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan.
Atsuhiro MasudaDepartment of Gastroenterology, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan.
Hideyuki ShiomiDepartment of Gastroenterology, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan.
Yuzo KodamaDepartment of Gastroenterology, Kobe University Graduate School of Medicine, Kusunokicho 7-5-2, Chuoku, Kobe, Hyogo, 650-0017, Japan.
Kobe University · JPHyogo Prefectural Amagasaki General Medical Center · JPKanazawa University Hospital · JPKobe City Medical Center General Hospital · JPOsaka Prefectural Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntimicrobial therapy with appropriate biliary drainage is considered the standard of care for acute cholangitis, but the optimal duration of antimicrobial therapy remains unknown. Seven to 10 days of antimicrobial therapy are common for the treatment of acute cholangitis, but a recent retrospective cohort study suggested a shorter duration might be effective. A shorter duration of antimicrobial therapy can be beneficial in decreasing the length of hospital stay, improving patients' quality of life, decreasing adverse effects, and even contributing to a decrease in the occurrence of antimicrobial resistance. METHODS/

designWe will conduct a multi-centre, open-label, randomized, non-inferiority trial to compare short-course therapy (SCT) with conventional long-course therapy (LCT) in treating patients with acute cholangitis. SCT consists of 5-day intravenous antimicrobial therapy if the patients had clinical improvement, while at least 7 days of intravenous antibiotics will be provided to the LCT group. The primary outcome is clinical cure at 30 days after onset. Patients will be randomly assigned in an open-label fashion. A total sample size of 150 was estimated to provide a power of 80% with a one-sided α level of 2.5% and a non-inferiority margin of 10%. DISCUSSION: This trial is expected to reveal whether SCT is non-inferior to conventional LCT or not, and may provide evidence that one can shorten the treatment duration for acute cholangitis for the benefit of patients.

trial registrationUniversity Hospital Medical Information Network, UMIN000028382. Registered on 30 August 2017.

Indexed as

Anti-Bacterial AgentsCholangitisDuration of TherapyAcute DiseaseCholangiopancreatography, Endoscopic RetrogradeDrainageEquivalence Trials as TopicHumansLength of StayMulticenter Studies as TopicAnti-Bacterial AgentsAcute cholangitisAntimicrobial therapyRCTShort-course therapy

Identifiers

PMID31952554
PMCPMC6969404
OpenAlexW2966884657

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.