Complicated Intra Abdominal InfectionsPhase 2/3SCAMPNCT01994993

Antibiotic Safety (SCAMP)

A Phase 2/3 study testing ampicillin and metronidazole and gentamicin, ampicillin and gentamicin and clindamycin and gentamicin and Piperacillin- tazobactam in people with Complicated Intra Abdominal Infections, run by Michael Cohen-Wolkowiez at 50 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages Up to 120 days
Conditions the study is for: Complicated Intra Abdominal Infections
What is being tested?: ampicillin and metronidazole and gentamicin, ampicillin and gentamicin and clindamycin and gentamicin and Piperacillin- tazobactam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 260 participants
Where: 50 sitesin 2 countries
Study dates: Dec 2013to 20 Apr 2017
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 120 days
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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)**
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.

Trial locations and contacts

50 sites in 2 countries.

Country

City, postcode or hospital

50 sites in 2 countries

United States45 sites

Georgia Regents University
Augusta, Georgia, 30912
University of Maryland Hospital
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111
Kings County Hospital
Brooklyn, New York, 11203
Brookdale University Hospital
Brooklyn, New York, 11212
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
Levine Children's Hospital
Charlotte, North Carolina, 28232
University of Virginia Health System
Charlottesville, Virginia, 22908
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27834
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Texas Children's Hospital
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Riley Hospital
Indianapolis, Indiana, 46202
University of Florida Jacksonville Healthcare, Inc.
Jacksonville, Florida, 32209
Wolfson Children's Hospital, Shands Medical Center
Jacksonville, Florida, 32209
University of Kentucky Hospital
Lexington, Kentucky, 40536
Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
Loma Linda University Medical Center
Loma Linda, California, 92354
University of Minnesota Fairview University Medical Center
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
New York University School of Medicine
New York, New York, 10016
Columbia University Neonatology
New York, New York, 10032
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
Stanford University School of Medicine
Palo Alto, California, 94304
Womens and Infant Hospital of Rhode Island
Providence, Rhode Island, 02905
WakeMed Faculty Neonatology
Raleigh, North Carolina, 27610
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Intermountain Medical Center
Salt Lake City, Utah, 84108
University of Utah
Salt Lake City, Utah, 84132
Rady Children's Hospital and Health Center
San Diego, California, 92123
University of California San Diego Medical Center
San Diego, California, 92123
Sharp Mary Birch
San Diego, California, 92131
Louisana State University Health Sciences Center
Shreveport, Louisiana, 71103
Westchester Medical Center - New York Medical College
Valhalla, New York, 10595
Wesley Medical Center
Wichita, Kansas, 67214
New Hanover Reginal Medical Center
Wilmington, North Carolina, 28403
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada5 sites

University of Alberta - Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Hospital Sainte-Justine
Montreal, Quebec, T3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
University of British Columbia - British Columbia Women's Hospital
Vancouver, British Columbia, V6H 3V4
Manitoba Institute of Child Health
Winnipeg, Manitoba, R3P 2C1

Other trials in Canada

About this study

Official title: Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)

Read the detailed description

The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.

Conditions: Complicated Intra Abdominal Infections
Being tested: 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
Keywords: Antibiotics, ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, Safety, Infants, Intra abdominal infections
Medical subject headings: Intraabdominal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ampicillin and metronidazole and gentamicinDrug
IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
ampicillin and gentamicin and clindamycinDrug
IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
gentamicin and Piperacillin- tazobactamDrug
IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
standard of care antibiotics and metronidazoleDrug
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)
metronidazole, clindamycin, or piperacillin-tazobactamDrug
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)

Study groups in NCT01994993
Study group	Role	What they receive
Group 1 (ampicillin +gentamycin +metronidazole)	Active comparator	Ampicillin and gentamycin and metronidazole Receives: Drug: ampicillin and metronidazole and gentamicin
Group 2 (ampicillin +gentamicin+clindamycin)	Active comparator	ampicillin and gentamicin and clindamycin Receives: Drug: ampicillin and gentamicin and clindamycin
Group 3 (piperacillin-tazobactam and gentamicin)	Active comparator	piperacillin-tazobactam and gentamicin Receives: Drug: gentamicin and Piperacillin- tazobactam
Group 4 (metronidazole)	Active comparator	Per standard of care antibiotics, and Metronidazole Receives: Drug: standard of care antibiotics and metronidazole
Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)	Active comparator	metronidazole, clindamycin, or piperacillin-tazobactam Receives: Drug: metronidazole, clindamycin, or piperacillin-tazobactam

What is being measured

The primary outcome is the main question the study is designed to answer.

Death
Number of Participants who experienced Death
Measured: Within 30 days after last dose of study drug, up to 40 days

Secondary outcomes (1)

Number of Participants With Therapeutic Success at Day 30
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
Measured: 30 days after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201320 Apr 2017

First posted26 Nov 2013 (estimated)
Study startDec 2013
Primary completion15 Jan 2017
Study completion20 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Complicated Intra Abdominal InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01994993
Sponsor's protocol ID: Pro00048773
Other IDs: HHSN275201000003I
Acronym: SCAMP
Status last verified: May 2019
First submitted: 18 Nov 2013
Last updated: 30 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK Jr, Hornik CP, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550-555. doi: 10.1097/INF.0000000000003034.
PubMed 33902072

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Complicated Intra Abdominal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
ClinicalTrials.gov ID: NCT01994993
Acronym / sponsor ID: SCAMP / Pro00048773
Conditions: Complicated Intra Abdominal Infections
Keywords: Antibiotics, ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, Safety, Infants, Intra abdominal infections
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Michael Cohen-WolkowiezUniversity, hospital or other
Collaborators: The Emmes Company, LLC
Study start: Dec 2013
Primary completion: 15 Jan 2017 (actual)
Study completion: 20 Apr 2017 (actual)
First posted: 26 Nov 2013 (estimated)
Results: Posted 27 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1 (ampicillin +gentamycin +metronidazole)	Active comparator	Drug: ampicillin and metronidazole and gentamicinAmpicillin and gentamycin and metronidazole
Group 2 (ampicillin +gentamicin+clindamycin)	Active comparator	Drug: ampicillin and gentamicin and clindamycinampicillin and gentamicin and clindamycin
Group 3 (piperacillin-tazobactam and gentamicin)	Active comparator	Drug: gentamicin and Piperacillin- tazobactampiperacillin-tazobactam and gentamicin
Group 4 (metronidazole)	Active comparator	Drug: standard of care antibiotics and metronidazolePer standard of care antibiotics, and Metronidazole
Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)	Active comparator	Drug: metronidazole, clindamycin, or piperacillin-tazobactammetronidazole, clindamycin, or piperacillin-tazobactam

Who may qualify

Ages: Up to 120 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (6 listed)

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)**
Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Group 1 (ampicillin +gentamycin +metronidazole)
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	Group 2 (ampicillin +gentamicin+clindamycin)
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	Group 3 (piperacillin-tazobactam and gentamicin)
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	Group 4 (metronidazole)
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)	Drug	Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)

Primary outcome

Death
Time frame: Within 30 days after last dose of study drug, up to 40 days
Number of Participants who experienced Death

1 secondary outcome

Number of Participants With Therapeutic Success at Day 30
Time frame: 30 days after last dose of study drug

Results and safety

Results posted to the registry on 27 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	63	28
Group 2	47	12
Group 3	70	23
Group 4	55	9
Group 5	24	22

Primary outcome: Death

Time frame: Within 30 days after last dose of study drug, up to 40 days. Count of participants. Unit: Participants

Measure	Group 1 n = 63	Group 2 n = 47	Group 3 n = 70	Group 4 n = 56	Group 5 n = 24
Value	5	5	7	1	0

Population analysed: Full intent-to-treat population (patients who received at least 1 dose of any study drug)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 90 days post last study dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	19 of 62 (30.6%)	10 of 62 (16.1%)	5 of 62
Group 2	10 of 46 (21.7%)	6 of 46 (13%)	5 of 46
Group 3	12 of 70 (17.1%)	10 of 70 (14.3%)	7 of 70
Group 4	3 of 55 (5.5%)	4 of 55 (7.3%)	1 of 55
Group 5	3 of 24 (12.5%)	9 of 24 (37.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33902072Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK Jr, Hornik CP, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550-555. doi: 10.1097/INF.0000000000003034.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Micheal Cohen-Wolkowiez, MD, PhD principal investigator

Duke University

50 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: Within 30 days after last dose of study drug, up to 40 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01994993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.