In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance
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| First Received Date ICMJE | September 19, 2009 | ||||
| Last Updated Date | June 21, 2011 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01132417 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance | ||||
| Official Title ICMJE | In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance | ||||
| Brief 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. |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Sputum, whole blood, urine, tissue |
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| 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). |
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| Condition ICMJE | Infections, Bacterial | ||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | Multidrug resistant (MDR)bacterial strains
Intervention: Drug: In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Saudi Arabia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01132417 | ||||
| Other Study ID Numbers ICMJE | 3074X1-4548 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wyeth Pharmaceuticals FZ-LLC, Middle East and North America Region, King Faisal University | ||||
| Study Sponsor ICMJE | King Faisal University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | King Faisal University | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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