Phase 3
Completed N=259
Antibiotic Safety (SCAMP)
Complicated Intra Abdominal Infections
Source: ClinicalTrials.gov NCT01994993 ↗
Enrolled (actual)
259
Serious AEs
18.3%
Results posted
Feb 2018
Primary outcomePrimary: Death — 5; 5; 7; 1 Participants
◆ Published Evidence
Emerging
16citations · ~3 / year
Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.
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
Linked Publications
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Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.