Phase 3
N=259
Antibiotic Safety (SCAMP)
Complicated Intra Abdominal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01994993 ↗Enrolled (actual)
259
Serious AEs
18.3%
Results posted
Feb 2018
Primary outcome: Primary: Death — 5; 5; 7; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ampicillin and metronidazole and gentamicin (Drug); ampicillin and gentamicin and clindamycin (Drug); gentamicin and Piperacillin- tazobactam (Drug); standard of care antibiotics and metronidazole (Drug); metronidazole, clindamycin, or piperacillin-tazobactam (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Michael Cohen-Wolkowiez
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death |
5; 5; 7; 1; 0 | — |
| SECONDARY Number of Participants With Therapeutic Success at Day 30 |
45; 39; 52; 52 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
- ≤33 weeks gestation at birth (Groups 1-3, 5)
- ≥34 weeks gestation at birth (Groups 4 and 5)
- PNA 2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)**
- 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)**
- 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.
Data sourced from ClinicalTrials.gov (NCT01994993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.