Evidence map›Paper›PMID 40000088›Full record

ArticleBMJ open2025

Tebipenem pivoxil as an alternative to ceftriaxone for clinically non-responding children with shigellosis: a randomised non-inferiority trial protocol.

Sharika Nuzhat, Md Ridwan Islam, Subhasish Das, Syed Jayedul Bashar, Patricia B Pavlinac, Samuel L Arnold, Amy Newlands, Rachel Gibson, Elena Fernandez Alvaro, Juliet Addo and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05121974 (Tebipenem-pivoxil as an Alternative to Ceftriaxone for Clinically Non-responding Children With Shigellosis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT05121974 phase2active not recruitingnot on this map

Tebipenem-pivoxil as an Alternative to Ceftriaxone for Clinically Non-responding Children With Shigellosis: a Randomized Non-inferiority Trial

TypeinterventionalSponsorInternational Centre for Diarrhoeal Disease Research, BangladeshRan2022 to 2026Enrolled132ConditionsShigellosisArmsTebipenem Pivoxil, Azithromycin, Ceftriaxon
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Sharika NuzhatNutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh sharika.nuzhat@icddrb.org.ORCID http://orcid.org/0000-0003-1057-9960
Md Ridwan IslamNutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
Subhasish DasNutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.ORCID http://orcid.org/0000-0002-7852-6569
Syed Jayedul BasharNutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
Patricia B PavlinacGlobal Health, University of Washington, Seattle, Washington, USA.ORCID http://orcid.org/0000-0002-0051-9131
Samuel L ArnoldDepartment of Pharmaceutics, University of Washington, Seattle, Washington, USA.
Amy NewlandsGlaxoSmithKline Research & Development Limited, Stevenage, UK.
Rachel GibsonGlobal Health, GlaxoSmithKline Plc, London, UK.
Elena Fernandez AlvaroGlaxoSmithKline Research & Development Limited, Stevenage, UK.
Juliet AddoGlaxoSmithKline Research & Development Limited, Stevenage, UK.
Farhana KhanamInfectious Diseases Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Dilruba AhmedLaboratory Sciences and Services Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
Md Jobayer ChistiNutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.ORCID http://orcid.org/0000-0001-9958-3071
Firdausi QadriInfectious Diseases Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Tahmeed AhmedClinical Sciences Division (CSD); Centre for Nutrition and Food Security (CNFS), International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.ORCID http://orcid.org/0000-0002-4607-7439

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionShigellosis is the second leading cause of diarrhoeal deaths among children worldwide. Oral azithromycin and intravenous ceftriaxone are the recommended first-line and second-line therapies for shigellosis in Bangladesh, respectively, but growing antibiotic resistance will require new antibiotic options. Tebipenem pivoxil, an orally administered carbapenem antibiotic with activity against many strains of antibiotic-resistant bacteria, may be a viable option.

methodsA phase IIb randomised controlled trial was planned to determine the efficacy and safety of oral tebipenem pivoxil, compared with intravenous ceftriaxone, for children with ETHICS AND DISSEMINATION: This study protocol was approved by the institutional review board of the International Centre for Diarrhoeal Disease Research, Bangladesh, which comprises a research review committee and an ethics review committee. In addition, the use of tebipenem pivoxil in shigellosis was approved by the Directorate General of Drug Administration of Bangladesh. TRIAL REGISTRATION NUMBER: NCT05121974.

Indexed as

Anti-Bacterial AgentsCarbapenemsCeftriaxoneDysentery, BacillaryAdministration, OralBangladeshChild, PreschoolClinical Trials, Phase II as TopicDiarrheaEquivalence Trials as TopicFemaleHumansInfantMaleRandomized Controlled Trials as TopicTreatment OutcomeAnti-Bacterial AgentsCarbapenemsCeftriaxonetebipenemCLINICAL PHARMACOLOGYClinical TrialPaediatric gastroenterologyProtocols & guidelines

Identifiers

PMID40000088
PMCPMC12083402

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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.