Open-label, Multiple-dose, Phase III Study of the Populat... | NCT00240747 | Trialant

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Open-label, Multiple-dose, Phase III Study of the Populat... | NCT00240747 | Trialant

Studies
Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

NCT00240747

Sponsor

Pfizer

Status

Terminated

Last Update Posted

May 25, 2012Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Gram-Positive Bacterial Infections

Interventions

Synercid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT00240747

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

RP59500V-324

Secondary IDs

Not provided

Brief Title

Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

Official Title

Not provided

Acronym

Not provided

Organization

PfizerINDUSTRY

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2000

Primary Completion Date

Not provided

Completion Date

Jan 2005

First Submitted Date

Oct 14, 2005

First Submission Date that Met QC Criteria

Oct 14, 2005

First Posted Date

Oct 18, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2012

Last Update Posted Date

May 25, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

PfizerINDUSTRY

Collaborators

Name	Class
Aventis Pharmaceuticals	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Brief 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.

Detailed Description

Not provided

Conditions Module

Conditions

Gram-Positive Bacterial Infections

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synercid	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Population pharmacokinetics

Secondary Outcomes

Measure	Description	Time Frame
Safety
Efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Serious, suspected or documented gram-positive infection

Exclusion Criteria:

-

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

27 Weeks

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Talbot, M.D.	Yale University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital		Oakland	California	94609	United States
Children's Hospital of Orange County

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Non-Randomized

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Orange

California

92868

United States

Duke University Medical Center

Durham

North Carolina

27705

United States

Children's Hospital

Cincinnati

Ohio

45267

United States

The Cleveland Clinic

Cleveland

Ohio

44195

United States

Children's Hospital at Saint Francis

Tulsa

Oklahoma

74136

United States

ID	Term
D016908	Gram-Positive Bacterial Infections

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C062940	quinupristin-dalfopristin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided