Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
260 participants
INTERVENTIONAL
2013-12-31
2017-04-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
NCT00621192
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
NCT01110382
Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
NCT00914888
Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis
NCT00195923
Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
NCT00879190
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 (ampicillin +gentamycin +metronidazole)
Ampicillin and gentamycin and metronidazole
ampicillin and metronidazole and gentamicin
IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Group 2 (ampicillin +gentamicin+clindamycin)
ampicillin and gentamicin and clindamycin
ampicillin and gentamicin and clindamycin
IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Group 3 (piperacillin-tazobactam and gentamicin)
piperacillin-tazobactam and gentamicin
gentamicin and Piperacillin- tazobactam
IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Group 4 (metronidazole)
Per standard of care antibiotics, and Metronidazole
standard of care antibiotics and metronidazole
IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)
metronidazole, clindamycin, or piperacillin-tazobactam
metronidazole, clindamycin, or piperacillin-tazobactam
IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ampicillin and metronidazole and gentamicin
IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
ampicillin and gentamicin and clindamycin
IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
gentamicin and Piperacillin- tazobactam
IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
standard of care antibiotics and metronidazole
IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
metronidazole, clindamycin, or piperacillin-tazobactam
IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ≤33 weeks gestation at birth (Groups 1-3, 5)
3. ≥34 weeks gestation at birth (Groups 4 and 5)
4. PNA \<121 days (Groups 1-5)
5. Sufficient venous access to permit administration of study drug (intravenous \[IV\]) (Groups 1-5)
6. Presenting physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection within 48 hours prior to randomization/first study drug dose (Groups 1-4)\*\*. Complicated intra-abdominal infections include secondary peritonitis, NEC grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous intestinal perforation, meconium ileus with perforation, bowel obstruction with perforation, gastroschisis with necrosis and/or perforation, omphalocele with necrosis and/or perforation, neonatal appendicitis, intestinal pneumatosis or portal venous gas, free peritoneal air on abdominal radiographic examination, or abdominal abscess.
7. Suspected or confirmed infection for which the study drug may provide therapeutic benefit and planned CSF collection per standard of care (Group 5).
Exclusion Criteria
2. Serum creatinine \>2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)\*\*
3. Known ALT \>250 U/L or AST \>500 U/L on measurement closest to the time of randomization or first study drug dose (Groups 1-5)\*\*
4. Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)
* Do not apply for Group 5 participants receiving drug per standard of care
* Criteria must be satisfied by randomization (randomized Groups 1-3) or first study drug dose (non-randomized Groups 1-3, Group 4 and Group 5), whichever comes first.
120 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Emmes Company, LLC
INDUSTRY
Michael Cohen-Wolkowiez
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michael Cohen-Wolkowiez
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Micheal Cohen-Wolkowiez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
Rady Children's Hospital and Health Center
San Diego, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Sharp Mary Birch
San Diego, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
University of Florida Jacksonville Healthcare, Inc.
Jacksonville, Florida, United States
Wolfson Children's Hospital, Shands Medical Center
Jacksonville, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Riley Hospital
Indianapolis, Indiana, United States
Wesley Medical Center
Wichita, Kansas, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
Louisana State University Health Sciences Center
Shreveport, Louisiana, United States
University of Maryland Hospital
Baltimore, Maryland, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States
University of Minnesota Fairview University Medical Center
Minneapolis, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Kings County Hospital
Brooklyn, New York, United States
Brookdale University Hospital
Brooklyn, New York, United States
New York University School of Medicine
New York, New York, United States
Columbia University Neonatology
New York, New York, United States
Westchester Medical Center - New York Medical College
Valhalla, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
WakeMed Faculty Neonatology
Raleigh, North Carolina, United States
New Hanover Reginal Medical Center
Wilmington, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Womens and Infant Hospital of Rhode Island
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
University of Alberta - Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of British Columbia - British Columbia Women's Hospital
Vancouver, British Columbia, Canada
Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital Sainte-Justine
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK Jr, Hornik CP, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550-555. doi: 10.1097/INF.0000000000003034.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HHSN275201000003I
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00048773
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.