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What is the primary objective of this study?

The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections

Who is eligible to participate?

Inclusion Criteria: 1. Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5) 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* 1. History of anaphylaxis in response to study drugs (Groups 1-5) 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Complicated Intra Abdominal Infections

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ampicillin and metronidazole and gentamicinIV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Drug:ampicillin and gentamicin and clindamycinIV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Drug:gentamicin and Piperacillin- tazobactamIV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Drug:standard of care antibiotics and metronidazoleIV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Drug:metronidazole, clindamycin, or piperacillin-tazobactamIV 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)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Group 1Ampicillin and gentamycin and metronidazole

Group 2ampicillin and gentamicin and clindamycin

Group 3piperacillin-tazobactam and gentamicin

Group 4Per standard of care antibiotics, and Metronidazole

Group 5metronidazole, clindamycin, or piperacillin-tazobactam

Study Status

Completed

Start Date: December 2013

Completed Date: April 20, 2017

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Death

Secondary Outcome: Number of Participants With Therapeutic Success at Day 30

Study sponsors, principal investigator, and references

Principal Investigator: Micheal Cohen-Wolkowiez, MD, PhD

Lead Sponsor: Michael Cohen-Wolkowiez

Collaborator: The EMMES Corporation

More information:https://clinicaltrials.gov/show/NCT01994993