Bacterial InfectionsPhase 3NCT00205816
Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
A Phase 3 study testing Tigecycline in people with Bacterial Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in 2 countries.
Trial summary
The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations. The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Tigecycline
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2004to Nov 2005
- Phase
- Phase 3
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
- Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
- Patient must give informed consent.
Who cannot join
- Patients with an expected survival of less than 2 weeks.
- Patients who have been designated as "Do Not Resuscitate".
- Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
- Pregnant women or nursing mothers.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.
The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.
The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.
- Conditions
- Bacterial Infections
- Being tested
- Tigecycline
- Keywords
- Bacterial Infections
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigecyclineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
response
Secondary outcomes (4)
micro response at subject level
micro response at pathogen level
clinical response at pathogen level
development of decreased susceptibility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205816
- Sponsor's protocol ID
- 3074A1-310
- Status last verified
- Feb 2013
- First submitted
- 16 Sep 2005
- Last updated
- 8 Feb 2013
- Results posted
- No
Publications
Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.
PubMed 24633206
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.
- ClinicalTrials.gov ID
- NCT00205816
- Acronym / sponsor ID
- 3074A1-310
- Conditions
- Bacterial Infections
- Keywords
- Bacterial Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.
The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
- Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
- Patient must give informed consent.
Key exclusion criteria (4 listed)
- Patients with an expected survival of less than 2 weeks.
- Patients who have been designated as "Do Not Resuscitate".
- Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
- Pregnant women or nursing mothers.
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 |
|---|---|---|
| Tigecycline | Drug | – |
Primary outcome
response
4 secondary outcomes
micro response at subject level
micro response at pathogen level
clinical response at pathogen level
development of decreased susceptibility
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Derived from this study: PubMed 24633206Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tigecycline in people with Bacterial Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in 2 countries.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00205816, which also lists 1 linked publication.
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 8 Feb 2013.