Evidence map›Paper›PMID 25964726›Full record

ReviewThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG

Reported rates of diarrhea following oral penicillin therapy in pediatric clinical trials.

Jemima Kuehn, Zareen Ismael, Paul F Long, Charlotte I S Barker, Mike Sharland

Registry-linked trialAbstract readReview
In one paragraph

Review in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05345457 (Outpatient Antibiotics Following Previable Rupture of Membranes), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
–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.

NCT05345457 phase4terminatednot on this map

Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

TypeinterventionalSponsorUniversity Hospitals Cleveland Medical CenterRan2023 to 2024Enrolled1ConditionsPregnancy Preterm, Pregnancy Prom, PROM, Preterm (Pregnancy), PROM (Pregnancy)ArmsAzithromycin Pill, Amoxicillin Pill
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Role ofFrontiers in pediatrics · 2026
    Article
  6. Observational
  7. Article
  8. Article
  9. The perfect storm: respiratory viral surges and anti-infective shortages.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2023
    Article
  10. Article
  11. NontypeableBiofilm · 2020
    Article
  12. Update on the adverse effects of antimicrobial therapies in community practice.Canadian family physician Medecin de famille canadien · 2020
    Review
  13. Canadian family physician Medecin de famille canadien · 2020
    Review
  14. A comparison of five paediatric dosing guidelines for antibiotics.Bulletin of the World Health Organization · 2020
    Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

5 authors.

Jemima KuehnPaediatric Infectious Diseases Unit, St George's Hospital, London, United Kingdom ; Cook County-Loyola-Provident Family Medicine Residency Program, Chicago, Illinois.
Zareen IsmaelInstitute of Pharmaceutical Science & Department of Chemistry, King's College, University of London, London, United Kingdom.
Paul F LongInstitute of Pharmaceutical Science & Department of Chemistry, King's College, University of London, London, United Kingdom.
Charlotte I S BarkerPaediatric Infectious Diseases Research Group, St George's University of London, London, United Kingdom.
Mike SharlandPaediatric Infectious Diseases Unit, St George's Hospital, London, United Kingdom ; Paediatric Infectious Diseases Research Group, St George's University of London, London, United Kingdom.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesAntibiotic-associated diarrhea (AAD) is a well-recognized adverse reaction to oral penicillins. This review analyzed the literature to determine the incidence of AAD following amoxicillin, amoxicillin/clavulanate, and penicillin V oral therapy in pediatric clinical trials.

methodsAn advanced search was conducted in MEDLINE and Embase databases for articles in any language reporting the incidence of AAD following oral penicillin therapy for any indicated infection in children (0-17 years). The search was limited to clinical trials. Articles were excluded if treatment was related to chronic conditions, involved concomitant antimicrobials, or if the dose or number of patients was not specified.

resultsFour hundred thirty-five articles relating to clinical trials were identified (307 from Embase; 128 from MEDLINE). Thirty-five articles reporting on 42 studies were included for analysis. The indications included acute otitis media, sinusitis, pharyngitis, and pneumonia. Thirty-three trials reported on amoxicillin/clavulanate, 6 on amoxicillin, and 3 on penicillin V. In total, the 42 trials included 7729 children who were treated with an oral penicillin. On average, 17.2% had AAD. Data were pooled for each penicillin. The AAD incidence was 19.8% for amoxicillin/clavulanate, 8.1% for amoxicillin, and 1.2% for penicillin V. The amoxicillin/clavulanate data were analyzed according to formulation: pooled-average. The incidence of ADD was 24.6% for the 4:1 formulation, 12.8% for the 7:1 formulation, 19.0% for the 8:1 formulation, and 20.2% for the 14:1 formulation.

conclusionsThese results demonstrate substantially increased incidence of AAD following use of amoxicillin/clavulanate, compared to use of amoxicillin and penicillin V, as well as varying AAD rates with diffierent amoxicillin/clavulanate formulations. These findings warrant consideration when prescribing. The underlying mechanisms of AAD in children remain unclear.

Indexed as

amoxicillinamoxicillin/clavulanateantibioticantibiotic-associated diarrheaoral penicillinspenicillin V

Identifiers

PMID25964726
PMCPMC4418686

What OpenQuestion holds

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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.