Community Acquired Bacterial PneumoniaPhase 3NCT01602874
Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
A Phase 3 study testing Tigecycline, cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside and CAP: Ceftriaxone, plus if applicable oral clarithromycin in people with Community Acquired Bacterial Pneumonia and Complicated Intra-Abdominal Infection, run by Pfizer.
Trial summary
The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal infections (cIAI) and community acquired pneumonia (CAP). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Community Acquired Bacterial Pneumonia, Complicated Intra-Abdominal Infection
- What is being tested?
- Tigecycline, cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside and CAP: Ceftriaxone, plus if applicable oral clarithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
- Have a diagnosis of a serious infection (complicated intra-abdominal infections [cIAI] or community acquired pneumonia [CAP] as applicable) requiring hospitalization and administration of IV antibiotic therapy.
- Criteria related indication (cIAI or CAP - as applicable), e.g., sign of systemic infection, signs and symptom.
Who cannot join
- Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy <30 days).
About this study
Official title: Multicenter, Randomized, And Double-Blind Study To Evaluate The Safety Of Tigecycline Versus A Ceftriaxone Regimen In The Treatment Of Complicated Intra-Abdominal Infections And Community-Acquired Pneumonia In Subjects Of 8-17 Years
The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal infections (cIAI) and community acquired pneumonia (CAP).
- Being tested
- Tigecycline, cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside, CAP: Ceftriaxone, plus if applicable oral clarithromycin
- Keywords
- children, pediatry, pneumonia, intra-abdominal, infection
- Medical subject headings
- Pneumonia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigecyclineDrug
Also called Tygacil
Subject with cIAI:
Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12 hours, metronidazole placebo IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside placebo IV may also be administered.
TigecyclineDrug
Also called Tygacil
Subject with CAP:
IV therapy period: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12h. At the discretion of the investigator oral clarithromycin placebo may be given every 12h.
Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).
cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycosideDrug
Subject with cIAI:
Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12 hours, metronidazole 10 mg/kg (maximum of 1 g/dose) IV will be administered every 8 hours.
In addition, at the discretion of the investigator, an aminoglycoside IV (adjusted dose if necessary) may also be given.
CAP: Ceftriaxone, plus if applicable oral clarithromycinDrug
Subject with CAP:
IV therapy period: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12h. At the discretion of the investigator, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).
Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).
| Study group | Role | What they receive |
|---|---|---|
| A. Tigecycline | Experimental | Not described Receives: Drug: Tigecycline |
| B. Ceftriaxone regimen | Active comparator | Not described Receives: Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside; Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy response (cure, failure, or indeterminate) at the test of cure (TOC) visit for 2 co-primary populations: the clinically evaluable (CE) and clinical modified Intent-to-Treat (c-mITT) populations
Measured: 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP
Secondary outcomes (5)
Clinical response at the IV last day of therapy (LDOT) for co-primary populations: the CE and c-mITT populations
Measured: 5 days to 4 weeks for cIAI and 5 days to 2 weeks for CAP
Clinical response at follow up (FUP) visits for co-primary populations: the CE and c-mITT populations
Measured: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Microbiological response at the subject and the pathogen level
Measured: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Response rate by pathogen and minimum inhibitory concentration (MIC) value
Measured: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations
Measured: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Bacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602874
- Sponsor's protocol ID
- 3074K4-3340
- Other IDs
- B1811003
- Status last verified
- Feb 2013
- First submitted
- 17 May 2012
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, And Double-Blind Study To Evaluate The Safety Of Tigecycline Versus A Ceftriaxone Regimen In The Treatment Of Complicated Intra-Abdominal Infections And Community-Acquired Pneumonia In Subjects Of 8-17 Years
- ClinicalTrials.gov ID
- NCT01602874
- Acronym / sponsor ID
- 3074K4-3340
- Keywords
- children, pediatry, pneumonia, intra-abdominal, infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal infections (cIAI) and community acquired pneumonia (CAP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. Tigecycline | Experimental | Drug: Tigecycline |
| B. Ceftriaxone regimen | Active comparator | Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside, Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
- Have a diagnosis of a serious infection (complicated intra-abdominal infections [cIAI] or community acquired pneumonia [CAP] as applicable) requiring hospitalization and administration of IV antibiotic therapy.
- Criteria related indication (cIAI or CAP - as applicable), e.g., sign of systemic infection, signs and symptom.
Key exclusion criteria (1 listed)
- Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy <30 days).
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 |
|---|---|---|
| TigecyclineAlso: TygacilSubject with cIAI: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12 hours, metronidazole placebo IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside placebo IV may also be administered. | Drug | A. Tigecycline |
| TigecyclineAlso: TygacilSubject with CAP: IV therapy period: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12h. At the discretion of the investigator oral clarithromycin placebo may be given every 12h. Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old). | Drug | A. Tigecycline |
| cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycosideSubject with cIAI: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12 hours, metronidazole 10 mg/kg (maximum of 1 g/dose) IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside IV (adjusted dose if necessary) may also be given. | Drug | B. Ceftriaxone regimen |
| CAP: Ceftriaxone, plus if applicable oral clarithromycinSubject with CAP: IV therapy period: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12h. At the discretion of the investigator, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old). Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old). | Drug | B. Ceftriaxone regimen |
Primary outcome
Clinical efficacy response (cure, failure, or indeterminate) at the test of cure (TOC) visit for 2 co-primary populations: the clinically evaluable (CE) and clinical modified Intent-to-Treat (c-mITT) populations
Time frame: 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP
5 secondary outcomes
Clinical response at the IV last day of therapy (LDOT) for co-primary populations: the CE and c-mITT populations
Time frame: 5 days to 4 weeks for cIAI and 5 days to 2 weeks for CAP
Clinical response at follow up (FUP) visits for co-primary populations: the CE and c-mITT populations
Time frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Microbiological response at the subject and the pathogen level
Time frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Response rate by pathogen and minimum inhibitory concentration (MIC) value
Time frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations
Time frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tigecycline, cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside and CAP: Ceftriaxone, plus if applicable oral clarithromycin in people with Community Acquired Bacterial Pneumonia and Complicated Intra-Abdominal Infection, run by Pfizer.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical efficacy response (cure, failure, or indeterminate) at the test of cure (TOC) visit for 2 co-primary populations: the clinically evaluable (CE) and clinical modified Intent-to-Treat (c-mITT) populations (time frame: 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2013.