Gram-Positive Bacterial InfectionsPhase 3NCT00240747
Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
A Phase 3 study testing Synercid in people with Gram-Positive Bacterial Infections, run by Pfizer at 6 sites in United States.
Trial summary
Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients. Read more about this study
- Who is it for?
- Ages 27 weeks to 16 years
- Conditions the study is for
- Gram-Positive Bacterial Infections
- What is being tested?
- Synercid
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Jun 2000to Jan 2005
- 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 27 weeks to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Serious, suspected or documented gram-positive infection
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Hospital
Cincinnati, Ohio, 45267
The Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27705
Children's Hospital
Oakland, California, 94609
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital at Saint Francis
Tulsa, Oklahoma, 74136
About this study
Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.
- Conditions
- Gram-Positive Bacterial Infections
- Being tested
- Synercid
- Medical subject headings
- Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynercidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Population pharmacokinetics
Secondary outcomes (2)
Safety
Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJun 2000
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Positive Bacterial InfectionsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aventis Pharmaceuticals
- Investigators
- George Talbot, M.D., Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240747
- Sponsor's protocol ID
- RP59500V-324
- Status last verified
- May 2012
- First submitted
- 14 Oct 2005
- Last updated
- 25 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
- ClinicalTrials.gov ID
- NCT00240747
- Acronym / sponsor ID
- RP59500V-324
- Conditions
- Gram-Positive Bacterial Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Jun 2000
- Study completion
- Jan 2005
- First posted
- 18 Oct 2005 (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.
Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 27 weeks to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Serious, suspected or documented gram-positive infection
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Synercid | Drug | – |
Primary outcome
Population pharmacokinetics
2 secondary outcomes
Safety
Efficacy
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
Related trials for Gram-Positive Bacterial Infections
Not yet recruitingObservational study
Optimised Dalbavancin Dosing for Serious Gram-Positive Bacterial Infections
Serious Gram-Positive Bacterial Infections
Active, not recruitingPhase 2/3
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruitingPhase 2
Oritavancin for Treatment of Serious Cardiac Infections
Infective Endocarditis, Cardiac Device Infection
Not yet recruiting
Oritavancin for CIED Infections With MDR Gram-positive Cocci
Cardiac Implantable Electronic Device Infections, Infective Endocarditis
RecruitingObservational study
Fosfomycin I.v. for Treatment of Severely Infected Patients
Bacterial Infections, Bone Diseases, Infectious
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.
George Talbot, M.D. study director
Yale University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Synercid in people with Gram-Positive Bacterial Infections, run by Pfizer at 6 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 1 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: stopped early, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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 stopped early. Results are not available in the source record.
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?
Population pharmacokinetics. 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 25 May 2012; AzTrials last refreshed its copy on 2 Nov 2026.