In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance

This study has suspended participant recruitment.

(researchers delay)

Sponsor:

Information provided by:

King Faisal University

ClinicalTrials.gov Identifier:

NCT01132417

First received: September 19, 2009

Last updated: June 21, 2011

Last verified: June 2011

History of Changes

Purpose

Observational: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Condition	Intervention
Infections, Bacterial	Drug: In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance

Resource links provided by NLM:

Drug Information available for: Tigecycline

U.S. FDA Resources

Further study details as provided by King Faisal University:

Biospecimen Retention: Samples Without DNA

Sputum, whole blood, urine, tissue

Estimated Enrollment:	500
Study Start Date:	September 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Multidrug resistant (MDR)bacterial strains	Drug: In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Detailed Description:

Study Phase Definition: Phase of investigation, as defined by the US FDA for trials involving investigational new drugs. Select only one.

N/A: for trials without phases Observational Study Design Case-control: group of individuals with specific characteristics (e.g., conditions or exposures) compared to group(s) with different Time Perspective Cross-sectional: observations or measurements made at a single point in time, usually at subject enrollment Biospecimen Retention - select one Samples Without DNA - samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma) Biospecimen Description

Sputum, whole blood, urine, tissue Enrollment

Single group study Number of Groups/Cohorts Definition: Number of study groups/cohorts. Enter 1 for a single-group study. Many observational studies have one group/cohort; case control studies typically have two.

One study group, anticipated samples in the rang of 400-500 samples 8. Arms, Groups and Interventions N/L Group/Cohort Label

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Definition: For observational studies only, a description of the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).

Criteria

Inclusion Criteria:

All patients with infection with MDRs infections will be included

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132417

Locations

Saudi Arabia
King Faisal Univrsity, Departmentof Microbiology and Immunology,, dammam branh
Dammam, Eastern, Saudi Arabia, 31451

Sponsors and Collaborators

King Faisal University

Investigators

Principal Investigator:

Asim E Ltayeb Diab, MD, Ph D

Assist. Professor and Consultant Microbiologist

More Information

No publications provided

Responsible Party:	Wyeth Pharmaceuticals FZ-LLC, Middle East and North America Region, King Faisal University
ClinicalTrials.gov Identifier:	NCT01132417 History of Changes
Other Study ID Numbers:	3074X1-4548
Study First Received:	September 19, 2009
Last Updated:	June 21, 2011
Health Authority:	Saudi Arabia: King Faisal University

Keywords provided by King Faisal University:

Tigecycline, MDR
Patient infected with multidrug resistance bacteria

Additional relevant MeSH terms:

Bacterial Infections
Tigecycline
Minocycline
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013

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