Trial · NCT01994993

Antibiotic Safety (SCAMP)

NCT01994993, Phase 2, Phase 3, Completed, Michael Cohen-Wolkowiez; results first posted 2018-02-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Antibiotic Safety (SCAMP). Trials, record NCT01994993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01994993

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Antibiotic Safety (SCAMP)
NCT number: NCT01994993
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 260 participants, actual
Lead sponsor: Michael Cohen-Wolkowiez
Conditions: Complicated Intra Abdominal Infections
Interventions: ampicillin and metronidazole and gentamicin, ampicillin and gentamicin and clindamycin, gentamicin and Piperacillin- tazobactam, standard of care antibiotics and metronidazole, metronidazole, clindamycin, or piperacillin-tazobactam
First posted: 2013-11-26
Last updated: 2019-05-30
Results first posted: 2018-02-27

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Death	Within 30 days after last dose of study drug, up to 40 days	Number of Participants who experienced Death
Secondary	Number of Participants With Therapeutic Success at Day 30	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
Other	Number of Participants With Feeding Intolerance	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
Other	Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)	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
Other	Number of Participants With Short Bowel Syndrome	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
Other	Number of Participants With Intestinal Perforation	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
Other	Number of Participants With Intestinal Stricture	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
Other	Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection	90 days after last dose of study drug	Progression is determined by the clinical NEC scoring
Other	Number of Participants With Gastrointestinal Surgeries	90 days after last dose of study drug	Determined by medical history and confirmed with hospital records. (Laparotomy)
Other	Number of Participants With Seizure	90 days after last dose of study drug	documented seizure(s) in hospital records

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Death	Within 30 days after last dose of study drug, up to 40 days	Full intent-to-treat population (patients who received at least 1 dose of any study drug)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Therapeutic Success at Day 30	30 days after last dose of study drug	Participants who received at least 1 dose of each study drug. Does not apply to Group 5.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Feeding Intolerance	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Short Bowel Syndrome	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Intestinal Perforation	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Intestinal Stricture	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Gastrointestinal Surgeries	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Seizure	90 days after last dose of study drug	Participant who received at least 1 dose of each study drug	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Death	Group 1	5	Participants
Death	Group 2	5	Participants
Death	Group 3	7	Participants
Death	Group 4	1	Participants
Death	Group 5	0	Participants
Number of Participants With Therapeutic Success at Day 30	Group 1	45	Participants
Number of Participants With Therapeutic Success at Day 30	Group 2	39	Participants
Number of Participants With Therapeutic Success at Day 30	Group 3	52	Participants
Number of Participants With Therapeutic Success at Day 30	Group 4	52	Participants
Number of Participants With Feeding Intolerance	Group 1	24	Participants

1 to 10 of 45Source ClinicalTrials.gov

See all 45 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1	63
Overall Study	STARTED	Group 2	47
Overall Study	STARTED	Group 3	70
Overall Study	STARTED	Group 4	55
Overall Study	STARTED	Group 5	24
Overall Study	COMPLETED	Group 1	28
Overall Study	COMPLETED	Group 2	12
Overall Study	COMPLETED	Group 3	23
Overall Study	COMPLETED	Group 4	9
Overall Study	COMPLETED	Group 5	22

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events240

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Thrombocytopenia	Blood and lymphatic system disorders	Group 1	4	62	5
other	Thrombocytopenia	Blood and lymphatic system disorders	Group 2	3	46	3
other	Thrombocytopenia	Blood and lymphatic system disorders	Group 3	4	70	4
other	Thrombocytopenia	Blood and lymphatic system disorders	Group 4	0	55	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Group 5	1	24	1
other	Anaemia	Blood and lymphatic system disorders	Group 1	3	62	7
other	Anaemia	Blood and lymphatic system disorders	Group 2	0	46	0
other	Anaemia	Blood and lymphatic system disorders	Group 3	1	70	1
other	Anaemia	Blood and lymphatic system disorders	Group 4	3	55	3
other	Anaemia	Blood and lymphatic system disorders	Group 5	0	24	0

1 to 10 of 240Source ClinicalTrials.gov

See all 240 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1	5	62
Total, all-cause mortality	Group 2	5	46
Total, all-cause mortality	Group 3	7	70
Total, all-cause mortality	Group 4	1	55
Total, all-cause mortality	Group 5	0	24
Total, other adverse events	Group 1	10	62
Total, other adverse events	Group 2	6	46
Total, other adverse events	Group 3	10	70
Total, other adverse events	Group 4	4	55
Total, other adverse events	Group 5	9	24

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33902072	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01994993

GET https://conductscience.org/api/trials/v1/NCT01994993/results?page=2

API reference For AI assistants