Evidence map›Paper›PMID 24795092›Full record

Trial reportJournal of gastroenterology2015

Clinical efficacy of intravenous doripenem in patients with acute biliary tract infection: a multicenter, randomized, controlled trial with imipenem/cilastatin as comparator.

Susumu Tazuma, Yoshinori Igarashi, Kazuo Inui, Hirotaka Ohara, Toshio Tsuyuguchi, Shomei Ryozawa, BTI Therapy Research Group

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. A meta-analysis of efficacy and safety of doripenem for treating bacterial infections.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    Pooled it
  2. Article
  3. Review
  4. Cholangiohepatitis in Dairy Cattle: 13 Cases.Journal of veterinary internal medicine · 2017
    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

7 authors at 6 institutions in 1 country.

Susumu TazumaDepartment of General Internal Medicine, Hiroshima University Graduate School of Medical Science, Programs of Applied Medicine, Clinical Pharmacotherapy, Hiroshima, Japan, stazuma@hiroshima-u.ac.jp.
Yoshinori Igarashi
Kazuo Inui
Hirotaka Ohara
Toshio Tsuyuguchi
Shomei Ryozawa
BTI Therapy Research Group
Chiba University · JPFujita Health University · JPHiroshima University · JPNagoya City University · JPSaitama International Medical Center · JPToho University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe conducted a randomized controlled trial to evaluate the clinical efficacy and safety of intravenous doripenem (DRPM) in patients with biliary tract infection requiring biliary drainage in comparison with imipenem/cilastatin (IPM/CS).

methodsAfter the initial collection of bile, patients were randomly assigned by the registration system of the Clinical Research Organization to receive intravenous drip infusion of DRPM 0.5 g or IPM/CS 0.5 g three times daily in a randomized, open-label manner.

resultsA total of 127 patients were enrolled in the trial (DRPM 62, IPM/CS 65). The characteristics of the 122 patients evaluated for efficacy were well balanced, except for the percentage of patients previously receiving antimicrobials, which was higher in the DRPM group than in the IPM/CS group. The clinical response rate was not significantly different between the DRPM group (93.1 %, 54/58 patients) and the IPM/CS group (93.8 %, 60/64). Non-inferiority assessment using confidence intervals demonstrated the non-inferiority of DRPM-IPM/CS. The incidence of adverse events, for which a causal relationship with either treatment was not ruled out, was 3.3 % (2/60) in the DRPM group and 3.1 % (2/65) in the IPM/CS group, and none was serious.

conclusionsThe clinical efficacy of DRPM in treating moderate or severe biliary tract infection requiring drainage was comparable to that of IPM/CS. DRPM was associated with no serious adverse events and a low incidence of adverse events. The results of this trial demonstrate that DRPM is a useful therapeutic option for moderate or severe biliary tract infection.

Indexed as

Acute DiseaseAdultAgedAged, 80 and overAnti-Bacterial AgentsBacterial InfectionsBody TemperatureCarbapenemsCholangitisCholecystitis, AcuteCilastatinCilastatin, Imipenem Drug CombinationC-Reactive ProteinDoripenemDrug CombinationsFemaleAnti-Bacterial AgentsCarbapenemsCilastatinCilastatin, Imipenem Drug CombinationC-Reactive ProteinDoripenemDrug CombinationsImipenem

Identifiers

PMID24795092
OpenAlexW2087805549

What OpenQuestion holds

Textmetadata
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.