Evidence map›Paper›PMID 31725114›Full record

ArticleThe Pediatric infectious disease journal2020

A Pharmacoepidemiologic Study of the Safety and Effectiveness of Clindamycin in Infants.

Rachel G Greenberg, Huali Wu, Anil Maharaj, Michael Cohen-Wolkowiez, Kay M Tomashek, Blaire L Osborn, Reese H Clark, Emmanuel B Walter

Open access · greenAbstract read
In one paragraph

Article in The Pediatric infectious disease journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  3. Review
  4. Antimicrobial resistance profile of methicillin-resistantFrontiers in cellular and infection microbiology · 2023
    Article
  5. 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

8 authors at 3 institutions in 1 country.

Rachel G GreenbergFrom the Duke Clinical Research Institute.
Huali WuFrom the Duke Clinical Research Institute.
Anil MaharajFrom the Duke Clinical Research Institute.
Michael Cohen-WolkowiezFrom the Duke Clinical Research Institute.
Kay M TomashekDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Blaire L OsbornDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Reese H ClarkDuke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.
Emmanuel B WalterFrom the Duke Clinical Research Institute.
Duke University · USClinical Research Institute · USNational Institute of Allergy and Infectious Diseases · US

Funding

Mentoring in Clinical Pharmacology and Early Phase TrialsK24AI143971 · NIAID · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2019 to 2023
$895k
NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS K24 AI143971
6 · The paper itself

Abstract

backgroundDespite the absence of adequate safety or efficacy data, clindamycin is widely prescribed in the neonatal intensive care unit. We evaluated the association between clindamycin exposure and adverse events, as well as antibiotic effectiveness in infants.

methodsThis was a retrospective cohort study of infants receiving clindamycin before postnatal day 121 who were discharged from a Pediatrix Medical Group neonatal intensive care unit (1997-2015). Using a previously developed pharmacokinetic model, we performed simulations to predict clindamycin exposure based on available dosing data. We used multivariable logistic regression to evaluate the association between clindamycin exposure and safety outcomes during and after clindamycin therapy. We reported the proportion of infants with methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and clearance of MRSA bacteremia.

resultsA total of 4089 infants received clindamycin at a median (25th-75th percentile) dose of 15 mg/kg/d (12-16). Clearance increased with older gestational age. Infants with the highest total clindamycin exposure had marginally increased odds of necrotizing enterocolitis within 7 days (adjusted odds ratio = 1.95 [1.04-3.63]), but exposure was not associated with death, sepsis, seizures, intestinal perforation or intestinal strictures. Of 25 infants who had MRSA bacteremia, 19 (76%) cleared the infection by the end of the clindamycin course.

conclusionsHigher clindamycin exposure was not associated with increased odds of death or nonlaboratory adverse events. The use of pharmacokinetic models combined with available electronic health record data offers a valuable, cost-effective approach to analyzing the safety and effectiveness of drugs in infants when large-scale trials are not feasible.

Indexed as

Anti-Bacterial AgentsClindamycinAge FactorsBacterial InfectionsDrug UtilizationFemaleHumansInfantInfant, NewbornOdds RatioPharmacoepidemiologyPrognosisRetrospective StudiesTreatment OutcomeAnti-Bacterial AgentsClindamycin

Identifiers

PMID31725114
PMCPMC7137351
OpenAlexW2988510203

What OpenQuestion holds

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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.