Evidence map›Paper›PMID 40970766›Full record

Trial reportAntimicrobial agents and chemotherapy2025

Metronidazole exposure-response and safety in infants.

Rachel L Randell, Stephen J Balevic, Rachel G Greenberg, Michael Cohen-Wolkowiez, Michael J Smith, Daniel K Benjamin, Catherine Bendel, Joseph M Bliss, Hala Chaaban, Rakesh Chhabra and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01994993 (Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections), 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.

NCT01994993 phase2 / phase3completednot on this map

Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)

TypeinterventionalSponsorMichael Cohen-WolkowiezRan2013 to 2017Enrolled260ConditionsComplicated Intra Abdominal InfectionsArmsampicillin and metronidazole and gentamicin, ampicillin and gentamicin and clindamycin, gentamicin and Piperacillin- tazobactam, standard of care antibiotics and metronidazole, metronidazole, clindamycin, or piperacillin-tazobactam
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

23 authors.

Rachel L RandellDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.ORCID 0000-0002-8009-8209
Stephen J BalevicDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.
Rachel G GreenbergDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.
Michael Cohen-WolkowiezDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.
Michael J SmithDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.
Daniel K BenjaminDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.
Catherine BendelDepartment of Pediatrics, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Joseph M BlissDepartment of Pediatrics, Division of Neonatology, University of Rochester Medical Center, Rochester, New York, USA.
Hala ChaabanDepartment of Pediatrics, Division of Neonatology, Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma, USA.
Rakesh ChhabraDepartment of Pediatrics, Division of Neonatology, Hackensack University Medical Center, Hackensack Meridian School of Medicine, Hackensack, New Jersey, USA.
Christiane E L DammannDepartment of Pediatrics, Tufts Medical Center, Tufts University, Boston, Massachusetts, USA.
L Corbin DowneyDepartment of Pediatrics, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
Chi D HornikDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.
Naveed HussainDepartment of Pediatrics, Division of Neonatology, Connecticut Children's, Hartford, Connecticut, USA.
Matthew M LaughonDepartment of Pediatrics, Division of Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Adrian LaveryChildren's Hospital of Orange County, Orange, California, USA.
Fernando MoyaPediatrix Medical Group, Austin, Texas, USA.
Matthew SaxonhouseDepartment of Pediatrics, Division of Neonatology, Levine Children's Hospital, Wake Forest School of Medicine Charlotte Campus, Atrium Healthcare, Charlotte, North Carolina, USA.
Gregory M SokolDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Andrea TrembathDivision of Neonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Joern-Hendrik WeitkampMildred Stahlman Division of Neonatology, Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Christoph P HornikDepartment of Pediatrics, Duke University, Durham, North Carolina, USA.ORCID 0000-0001-7056-8759
Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee

Funding

Mentoring in Pediatric Cardiovascular Pharmacology and Early Phase TrialsK24HL173596 · NHLBI · DUKE UNIVERSITY · PI Christoph Hornik · 2024 to 2026
$363k
NHLBI NIH HHS 1K24HL173596NHLBI NIH HHS K24 HL173596NICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS HHSN275201700002CNICHD NIH HHS HHSN275201800003I
6 · The paper itself

Abstract

The nitroimidazole antibiotic, metronidazole, is frequently prescribed to infants with serious intra-abdominal infections, and multiple dosing recommendations exist. We sought to evaluate the extent to which metronidazole doses and associated exposures achieved desired efficacy and safety in infants enrolled in the Antibiotic Safety in Infants with Complicated Intra-abdominal Infections (SCAMP) trial (NCT01994993). SCAMP participants received intravenous metronidazole as part of multimodal antimicrobial therapy. Participants received a 15 mg/kg loading dose and a 7.5 mg/kg maintenance dose at 24 h. A subsequent 7.5 mg/kg maintenance dose was administered every 12 h for participants of postmenstrual age (PMA) 23 to <34 weeks; 8 h for PMA 34-40 weeks; and 6 h for PMA >40 weeks. We evaluated associations between simulated metronidazole exposures and pre-specified surrogate pharmacodynamic targets and clinical outcomes of efficacy and safety. Nearly 100% of pharmacodynamic targets were met. Infants with therapeutic success (a composite efficacy outcome, defined as the absence of death, negative bacterial blood cultures, and presumptive clinical cure at 30 days) had higher

Indexed as

Anti-Bacterial AgentsIntraabdominal InfectionsMetronidazoleEnterocolitis, NecrotizingFemaleHumansInfantInfant, NewbornMaleAnti-Bacterial AgentsMetronidazolemetronidazolepediatricpharmacodynamicssafety

Identifiers

PMID40970766
PMCPMC12587542

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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.