Antibiotic Safety (SCAMP) (SCAMP)
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ClinicalTrials.gov Identifier: NCT01994993 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Results First Posted : February 27, 2018
Last Update Posted : May 30, 2019
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Condition or disease | Intervention/treatment | Phase |
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Complicated Intra Abdominal Infections | Drug: 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 | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial) |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | January 15, 2017 |
Actual Study Completion Date : | April 20, 2017 |
Arm | Intervention/treatment |
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Active Comparator: Group 1 (ampicillin +gentamycin +metronidazole)
Ampicillin and gentamycin and metronidazole
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Drug: 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) |
Active Comparator: Group 2 (ampicillin +gentamicin+clindamycin)
ampicillin and gentamicin and clindamycin
|
Drug: 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) |
Active Comparator: Group 3 (piperacillin-tazobactam and gentamicin)
piperacillin-tazobactam and gentamicin
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Drug: 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) |
Active Comparator: Group 4 (metronidazole)
Per standard of care antibiotics, and Metronidazole
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Drug: 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) |
Active Comparator: Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)
metronidazole, clindamycin, or piperacillin-tazobactam
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Drug: 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) |
- Death [ Time Frame: Within 30 days after last dose of study drug, up to 40 days ]Number of Participants who experienced Death
- Number of Participants With Therapeutic Success at Day 30 [ Time Frame: 30 days after last dose of study drug ]
Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score >4.
Clinical cure score =1 for each of the following elements:
FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment
- Number of Participants With Feeding Intolerance [ Time Frame: 90 days after last dose of study drug ]Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed
- Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH) [ Time Frame: 90 days after last dose of study drug ]
Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement
Grade 4 IVH: Intraparenchymal hemorrhage
- Number of Participants With Short Bowel Syndrome [ Time Frame: 90 days after last dose of study drug ]
Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve.
Total parenteral nutrition for >42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age
- Number of Participants With Intestinal Perforation [ Time Frame: 90 days after last dose of study drug ]
Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis.
Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement
- Number of Participants With Intestinal Stricture [ Time Frame: 90 days after last dose of study drug ]
Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis.
Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement
- Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection [ Time Frame: 90 days after last dose of study drug ]Progression is determined by the clinical NEC scoring
- Number of Participants With Gastrointestinal Surgeries [ Time Frame: 90 days after last dose of study drug ]Determined by medical history and confirmed with hospital records. (Laparotomy)
- Number of Participants With Seizure [ Time Frame: 90 days after last dose of study drug ]documented seizure(s) in hospital records
- Number of Participants With Positive Blood Cultures [ Time Frame: 90 days after last dose of study drug ]Positive blood culture (bacterial or fungal)

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Ages Eligible for Study: | up to 120 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 <121 days (Groups 1-5)
- Sufficient venous access to permit administration of study drug (intravenous [IV]) (Groups 1-5)
- 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.
- 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*
- History of anaphylaxis in response to study drugs (Groups 1-5)
- Serum creatinine >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)**
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Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)
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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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994993

Principal Investigator: | Micheal Cohen-Wolkowiez, MD, PhD | Duke University |
Responsible Party: | Michael Cohen-Wolkowiez, Associate Professor, Duke University |
ClinicalTrials.gov Identifier: | NCT01994993 |
Other Study ID Numbers: |
Pro00048773 HHSN275201000003I ( Other Grant/Funding Number: NICHD ) |
First Posted: | November 26, 2013 Key Record Dates |
Results First Posted: | February 27, 2018 |
Last Update Posted: | May 30, 2019 |
Last Verified: | May 2019 |
Antibiotics ampicillin metronidazole clindamycin |
piperacillin-tazobactam Safety Infants Intra abdominal infections |
Infection Intraabdominal Infections Anti-Bacterial Agents Metronidazole Clindamycin Clindamycin palmitate Clindamycin phosphate Gentamicins Tazobactam Piperacillin |
Ampicillin Piperacillin, Tazobactam Drug Combination Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action beta-Lactamase Inhibitors |