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NCT01132417 Clinical Trial

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

Infections, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01132417
Other study ID # 3074X1-4548
Secondary ID
Status Suspended
Phase N/A
First received September 19, 2009
Last updated June 21, 2011
Start date September 2009
Est. completion date July 2012

Study information
Verified date June 2011
Source King Faisal University
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: King Faisal University
Study type Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Suspended
Enrollment 500
Est. completion date July 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with infection with MDRs infections will be included

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Saudi Arabia King Faisal Univrsity, Departmentof Microbiology and Immunology,, dammam branh Dammam Eastern

Sponsors (1)
Lead Sponsor Collaborator
King Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

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