Infections, BacterialNCT01132417
In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance
An observational study of Infections, Bacterial, run by King Faisal University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections, Bacterial
- What is being tested?
- In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance
- How many people
- 500 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2009to Jul 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- All patients with infection with MDRs infections will be included
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Univrsity, Departmentof Microbiology and Immunology,, dammam branh
Dammam, Eastern Province, 31451
About this study
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.
Read the 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
- Conditions
- Infections, Bacterial
- Being tested
- In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance
- Keywords
- Tigecycline, MDR, Patient infected with multidrug resistance bacteria
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistanceDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Multidrug resistant (MDR)bacterial strains | Not described Receives: Drug: In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: researchers delay
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, BacterialStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal University
- Sponsor type
- University, hospital or other
- Investigators
- Asim E Ltayeb Diab, MD, Ph D, Principal investigator, Assist. Professor and Consultant Microbiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132417
- Sponsor's protocol ID
- 3074X1-4548
- Status last verified
- Jun 2011
- First submitted
- 19 Sep 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance
- ClinicalTrials.gov ID
- NCT01132417
- Acronym / sponsor ID
- 3074X1-4548
- Conditions
- Infections, Bacterial
- Keywords
- Tigecycline, MDR, Patient infected with multidrug resistance bacteria
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: researchers delay
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King Faisal UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 28 May 2010 (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.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidrug resistant (MDR)bacterial strains | – | Drug: In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- All patients with infection with MDRs infections will be included
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistancestudies 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. | Drug | Multidrug resistant (MDR)bacterial strains |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Asim E Ltayeb Diab, MD, Ph D principal investigator
Assist. Professor and Consultant Microbiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Bacterial, run by King Faisal University at 1 site in Saudi Arabia.
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: paused, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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.
Are results available for this study?
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.
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 23 Jun 2011.