Necrotizing EnterocolitisPhase 1/2NCT00621192

Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections

A Phase 1/2 study testing meropenem in people with Necrotizing Enterocolitis and Intra-abdominal Infection, run by The Emmes Company, LLC at 26 sites in United States.

Completed

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

Official record

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Trial summary

Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these… Read more about this study

Who is it for?: Ages Up to 90 days
Conditions the study is for: Necrotizing Enterocolitis, Intra-abdominal Infection
What is being tested?: meropenem
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 26 sitesUnited States
Study dates: Jun 2008to Oct 2009
Phase: Phase 1/2
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 90 days
All sexes
No healthy volunteers
Child

Who may be able to join

Written permission from parent or legal guardian
Age younger than 91 days
Likely to survive beyond the first 48 hours after enrollment
Sufficient intravascular access (either peripheral or central) to receive study drug.
AND ONE OF THE FOLLOWING
1) Physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection. These include peritonitis, NEC (Necrotizing Enterocolitis) Grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous perforation, meconium ileus with perforation, bowel obstruction with perforation, as evidenced by free peritoneal air on abdominal radiograph, intestinal pneumatosis or portal venous gas on abdominal radiographic examination.
OR 2) Possible NEC OR 3) Otherwise receiving meropenem per local standard of care

Who cannot join

Renal dysfunction evidenced by urine output <0.5 mL/hr/kg over the prior 24 hours
Serum creatinine >1.7 mg/dL
History of clinical seizures or EEG (Electroencephalogram) confirmed seizures
Concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent
Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Akron Children's Hospital
Akron, Ohio, 44308
Albany Medical Center
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama
Birmingham, Alabama, 35233
Suny Downstate Medical Center
Brooklyn, New York, 11203
Case Western Reserve, RB&C, UHCMC
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27708
Duke University
Durham, North Carolina, 27715
Evanston Northwestern Healthcare
Evanston, Illinois, 60056
University of Florida
Gainesville, Florida, 32610
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Baylor College of Medicine
Houston, Texas, 77030
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, 46202
Kansas City Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Louisville
Louisville, Kentucky, 40202
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06510
Children's Hospital of Oakland
Oakland, California, 94609
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
University of Utah medical Center
Salt Lake City, Utah, 84108
University of California Medical Center
San Diego, California, 92117
Sharp-Mary Birch Hospital for Women
San Diego, California, 92123
Children's National Medical Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-abdominal Infections

Read the detailed description

This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections.

The specific aims of this trial are:

To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections.
To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Conditions: Necrotizing Enterocolitis, Intra-abdominal Infection
Being tested: meropenem
Keywords: meropenem, infants, intra-abdominal infection, pharmacokinetics, safety
Medical subject headings: Enterocolitis, Necrotizing, Intraabdominal Infections

What participants receive

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

meropenemDrug
Also called Merrem
Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant.
20 mg/kg every 12 hours in infants <32 weeks GA and PNA < 2 weeks 20 mg/kg every 8 hours in infants <32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA < 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks

Study groups in NCT00621192
Study group	Role	What they receive
Meropenem	Experimental	These Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA): Group 1: GA at birth below 32 weeks - PNA <2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and <91 days; Group 3: GA at birth 32 weeks or older - PNA <2 weeks; Group 4: GA at birth 32 weeks or older - PNA ≥2 weeks and <91 days. Receives: Drug: meropenem

What is being measured

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

Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)
The PCCS was derived by comparing clinical signs and symptoms prior to administration of the first dose of study drug and study Day 28.The elements of the PCCS include Mean BP,Temp,PaO2(mmHg)/FiO2,Lowest serum pH,seizures,Urine output,Cardiovascular inotrope support,C-reactive protein (CRP)and Abdominal girth.
Score - Asymptomatic to Asymptomatic 1;Asymptomatic to Worsening 0;Symptomatic to Worsening 0;Symptomatic to No change 0;Symptomatic to Improved 1;Symptomatic to Asymptomatic 1
If 7 or more of 10 signs received a score of 1, then the infant was considered a presumptive clinical cure.
GA stands for Gestational Age and PNA stands for Postnatal Age.
Measured: Average of 12 days (3 to 21 days)
Deaths
Measured: Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug)
Meropenem Clearance
Given the limited availability of blood for Pharmacokinetic (PK) assessments in this population a sparse sampling approach was utilized. Subjects were assigned to one of two Dose 1 sample collection schedules, "PK-odd" and "PK-even" based on birth date to ensure collection of PK data throughout the dose interval. In addition, PK samples were collected around approximately the 5th dose. Subjects that did not have Dose 1 PK samples could have steady-state (Dose 5) using the Dose 5 PK collection schedule.
Measured: Up to 7-8hrs post drug administration
Key Safety Endpoints
Safety assessments included death, seizure documentation (including correlation of serum meropenem level and seizures), strictures, perforation, wound dehiscence, short gut, development of extended beta lactamase infection, development of candidiasis, antimicrobial therapy failure
Measured: Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the 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.

Jun 2008Oct 2009

First posted22 Feb 2008 (estimated)
Study startJun 2008
Primary completionOct 2009
Study completionOct 2009

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 Necrotizing EnterocolitisStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621192
Sponsor's protocol ID: HHSN267200700051C
Other IDs: HHSN267200700051C
Status last verified: Mar 2023
First submitted: 20 Feb 2008
Last updated: 25 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cohen-Wolkowiez M, Poindexter B, Bidegain M, Weitkamp JH, Schelonka RL, Randolph DA, Ward RM, Wade K, Valencia G, Burchfield D, Arrieta A, Mehta V, Walsh M, Kantak A, Rasmussen M, Sullivan JE, Finer N, Rich W, Brozanski BS, van den Anker J, Blumer J, Laughon M, Watt KM, Kearns GL, Capparelli EV, Martz K, Berezny K, Benjamin DK Jr, Smith PB; Meropenem Study Team. Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections. Clin Infect Dis. 2012 Dec;55(11):1495-502. doi: 10.1093/cid/cis758. Epub 2012 Sep 5.
PubMed 22955430

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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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
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All Necrotizing Enterocolitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-abdominal Infections
ClinicalTrials.gov ID: NCT00621192
Acronym / sponsor ID: HHSN267200700051C
Conditions: Necrotizing Enterocolitis, Intra-abdominal Infection
Keywords: meropenem, infants, intra-abdominal infection, pharmacokinetics, safety
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: The Emmes Company, LLCIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 29 Nov 2011

Clinical summary

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

Detailed description

This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections.

The specific aims of this trial are:

To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections.
To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Meropenem	Experimental	Drug: meropenemThese Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA): Group 1: GA at birth below 32 weeks - PNA <2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and <91 days; Group 3: GA at birth 32 weeks or older - PNA <2 weeks; Group 4: GA at birth 32 weeks or older - PNA ≥2 weeks and <91 days.

Who may qualify

Ages: Up to 90 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Written permission from parent or legal guardian
Age younger than 91 days
Likely to survive beyond the first 48 hours after enrollment
Sufficient intravascular access (either peripheral or central) to receive study drug.
AND ONE OF THE FOLLOWING

Key exclusion criteria (5 listed)

Renal dysfunction evidenced by urine output <0.5 mL/hr/kg over the prior 24 hours
Serum creatinine >1.7 mg/dL
History of clinical seizures or EEG (Electroencephalogram) confirmed seizures
Concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent
Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study

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
meropenemAlso: MerremMeropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant. 20 mg/kg every 12 hours in infants <32 weeks GA and PNA < 2 weeks 20 mg/kg every 8 hours in infants <32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA < 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks	Drug	Meropenem

Primary outcome

Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)
Time frame: Average of 12 days (3 to 21 days)
The PCCS was derived by comparing clinical signs and symptoms prior to administration of the first dose of study drug and study Day 28.The elements of the PCCS include Mean BP,Temp,PaO2(mmHg)/FiO2,Lowest serum pH,seizures,Urine output,Cardiovascular inotrope support,C-reactive protein (CRP)and Abdominal girth. Score - Asymptomatic to Asymptomatic 1;Asymptomatic to Worsening 0;Symptomatic to Worsening 0;Symptomatic to No change 0;Symptomatic to Improved 1;Symptomatic to Asymptomatic 1 If 7 or more of 10 signs received a score of 1, then the infant was considered a presumptive clinical cure. GA stands for Gestational Age and PNA stands for Postnatal Age.
Deaths
Time frame: Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug)
Meropenem Clearance
Time frame: Up to 7-8hrs post drug administration
Given the limited availability of blood for Pharmacokinetic (PK) assessments in this population a sparse sampling approach was utilized. Subjects were assigned to one of two Dose 1 sample collection schedules, "PK-odd" and "PK-even" based on birth date to ensure collection of PK data throughout the dose interval. In addition, PK samples were collected around approximately the 5th dose. Subjects that did not have Dose 1 PK samples could have steady-state (Dose 5) using the Dose 5 PK collection schedule.
Key Safety Endpoints
Time frame: Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug)
Safety assessments included death, seizure documentation (including correlation of serum meropenem level and seizures), strictures, perforation, wound dehiscence, short gut, development of extended beta lactamase infection, development of candidiasis, antimicrobial therapy failure

Results and safety

Results posted to the registry on 29 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1. GA <32 Wks; PNA<2 Wks	39	35
2. GA <32 Wks; PNA 91days ≥ 2Wks	103	94
3. GA ≥ 32 Wks; PNA <2 Wks	31	26
4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks	27	24

Primary outcome: Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)

Time frame: Average of 12 days (3 to 21 days). Number. Unit: Participants

Measure	1. GA <32 Wks; PNA<2 Wks n = 39	2. GA <32 Wks; PNA 91days ≥ 2Wks n = 98	3. GA ≥ 32 Wks; PNA <2 Wks n = 28	4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks n = 27
Value	29	82	26	25

Population analysed: The Efficacy Population includes all patients who have efficacy assessment (Clinical Signs) at Pre-Dose and Study Day 28 (or the day that the Day 28 assessments were taken).

Primary outcome: Deaths

Time frame: Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug). Number. Unit: Participants

Measure	1. GA <32 Wks; PNA<2 Wks n = 39	2. GA <32 Wks; PNA 91days ≥ 2Wks n = 103	3. GA ≥ 32 Wks; PNA <2 Wks n = 31	4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks n = 27
Value	3	8	0	0

Population analysed: The Safety Population includes all patients who receive any amount of meropenem.

Primary outcome: Meropenem Clearance

Time frame: Up to 7-8hrs post drug administration. Mean (Standard Deviation). Unit: L/h/kg

Measure	1. GA <32 Wks; PNA<2 Wks n = 39	2. GA <32 Wks; PNA 91days ≥ 2Wks n = 98	3. GA ≥ 32 Wks; PNA <2 Wks n = 28	4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks n = 27
Value	0.089 (0.027)	0.122 (0.037)	0.135 (0.040)	0.202 (0.061)

Primary outcome: Key Safety Endpoints

Time frame: Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug). Number. Unit: Participants

Measure	1. GA <32 Wks; PNA<2 Wks n = 39	2. GA <32 Wks; PNA 91days ≥ 2Wks n = 103	3. GA ≥ 32 Wks; PNA <2 Wks n = 31	4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks n = 27
Death	3 (1.6% to 20.9%)	8	0	0
Seizure	4	3	1	2
Strictures	0	0	0	0
Perforation	2	2	0	0
Wound Dehiscence	1	1	1	1
Development of Candidiasis	5	3	0	0
Antimicrobial Therapy Failure	7	12	2	2

Population analysed: Safety Population - The Safety Population includes all patients who receive any amount of meropenem.

Adverse events

Time frame: Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug for non-Serious Adverse Events (SAEs) and until 30 days after the last dose of study drug for SAEs.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1. GA <32 Wks; PNA<2 Wks	9 of 39 (23.1%)	9 of 39 (23.1%)	Not reported
2. GA <32 Wks; PNA 91days ≥ 2Wks	18 of 103 (17.5%)	8 of 103 (7.8%)	Not reported
3. GA ≥ 32 Wks; PNA <2 Wks	2 of 31 (6.5%)	2 of 31 (6.5%)	Not reported
4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks	5 of 27 (18.5%)	3 of 27 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22955430Cohen-Wolkowiez M, Poindexter B, Bidegain M, Weitkamp JH, Schelonka RL, Randolph DA, Ward RM, Wade K, Valencia G, Burchfield D, Arrieta A, Mehta V, Walsh M, Kantak A, Rasmussen M, Sullivan JE, Finer N, Rich W, Brozanski BS, van den Anker J, Blumer J, Laughon M, Watt KM, Kearns GL, Capparelli EV, Martz K, Berezny K, Benjamin DK Jr, Smith PB; Meropenem Study Team. Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections. Clin Infect Dis. 2012 Dec;55(11):1495-502. doi: 10.1093/cid/cis758. Epub 2012 Sep 5.

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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.

Danny Benjamin, MD, PhD, MPH principal investigator

Duke University

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing meropenem in people with Necrotizing Enterocolitis and Intra-abdominal Infection, run by The Emmes Company, LLC at 26 sites in United States.

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 5 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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 29 Nov 2011). 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?

Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit) (time frame: Average of 12 days (3 to 21 days)). The study lists 4 primary outcomes in all. 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 NCT00621192, 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 25 Apr 2023.