Antibiotic Resistant InfectionPhase 4NCT01342731
Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
A Phase 4 study testing Tigecycline in people with Antibiotic Resistant Infection, run by Mahidol University at 1 site in Thailand.
Trial summary
30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will be enrolled. The eligible patients will receive 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- Tigecycline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2011to Dec 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized male or female aged 18 years or older
- Has documented infection due to A. baumannii resistant to cephalosporins, beta-lactams/ beta-lactamase inhibitors, aminoglycosides, fluoroquinolones and carbapenems
- Willing to join the study by signing a written informed consent form
Who cannot join
- Pregnant or lactating woman
- Has contraindication for receiving tigecycline such as allergy to tetracycline
- Has received colistin for more than 24 hours
- Unable to receive tigecycline monotherapy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, Bangkok, 10700
Visanu Thamlikitkul, MD, 662-412-5994, sivth@mahidol.ac.th
Peerawong Weerarak, MD
About this study
30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will be enrolled. The eligible patients will receive 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days. Clinical outcomes on effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of clinical specimen from the site of infection will be obtained on day 3 and at the end of tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse, death. Microbiological outcome is assessed at the end of treatment and classified as eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day mortality and infection-related mortality will be determined. Length of stay will also be determined.
Read the detailed description
Objectives:
To determine effectiveness and safety of tigecycline for therapy of hospitalized patients with infections due to MDR A. baumannii.
Study Design Open label phase IV study
Sample Size:
It is estimated that a favorable response rate in patients infected with MDR A. baumannii who received tigecycline is 60% +/- 20% with 5% type I error. Therefore the estimated sample size is 24 patients. This study will enroll 30 patients in order to compensate for some patients who may not be available to have a complete follow up.
Study Procedures:
All eligible patients will be identified through the pharmacy database and microbiology database on daily basis. The investigator will obtain written consent from each potential patient. Consent must be documented by the patient's dated signature on a consent form along with the dated signature of the person conducting the consent discussion. If the patient is in the state that can not make decision, the written consent of a parent, legal guardian or legal representative must be obtained. Intervention: The eligible patients will receive 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
Evaluation/Follow - Up:
Clinical outcomes on effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of clinical specimen from the site of infection will be obtained on day 3 and at the end of tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse, death. Microbiological outcome is assessed at the end of treatment and classified as eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day mortality and infection-related mortality will be determined. Length of stay will also be determined.
- Conditions
- Antibiotic Resistant Infection
- Being tested
- Tigecycline
- Keywords
- Tigecycline, A.baumannii, Drug safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigecyclineDrug
Also called Tygacil
100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Tigecycline | Experimental | Tigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d Receives: Drug: Tigecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Clinical response is classified as cure, improvement, failure, relapse, death.
Measured: at the end of therapy (up to 28 days)
Secondary outcomes (1)
Microbiological outcomes
Microbiological outcome is classified as eradication, persistence, colonization, and superinfection.
Measured: At the end of therapy (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visanu Thamlikitkul, Mahidol University
- Investigators
- Visanu Thamlikitkul, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342731
- Sponsor's protocol ID
- CEU 003-11
- Status last verified
- Jan 2012
- First submitted
- 21 Apr 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
- ClinicalTrials.gov ID
- NCT01342731
- Acronym / sponsor ID
- CEU 003-11
- Conditions
- Antibiotic Resistant Infection
- Keywords
- Tigecycline, A.baumannii, Drug safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Apr 2011 (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.
30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will be enrolled. The eligible patients will receive 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days. Clinical outcomes on effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of clinical specimen from the site of infection will be obtained on day 3 and at the end of tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse, death. Microbiological outcome is assessed at the end of treatment and classified as eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day mortality and infection-related mortality will be determined. Length of stay will also be determined.
Detailed description
Objectives:
To determine effectiveness and safety of tigecycline for therapy of hospitalized patients with infections due to MDR A. baumannii.
Study Design Open label phase IV study
Sample Size:
It is estimated that a favorable response rate in patients infected with MDR A. baumannii who received tigecycline is 60% +/- 20% with 5% type I error. Therefore the estimated sample size is 24 patients. This study will enroll 30 patients in order to compensate for some patients who may not be available to have a complete follow up.
Study Procedures:
All eligible patients will be identified through the pharmacy database and microbiology database on daily basis. The investigator will obtain written consent from each potential patient. Consent must be documented by the patient's dated signature on a consent form along with the dated signature of the person conducting the consent discussion. If the patient is in the state that can not make decision, the written consent of a parent, legal guardian or legal representative must be obtained. Intervention: The eligible patients will receive 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
Evaluation/Follow - Up:
Clinical outcomes on effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of clinical specimen from the site of infection will be obtained on day 3 and at the end of tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse, death. Microbiological outcome is assessed at the end of treatment and classified as eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day mortality and infection-related mortality will be determined. Length of stay will also be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tigecycline | Experimental | Drug: TigecyclineTigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized male or female aged 18 years or older
- Has documented infection due to A. baumannii resistant to cephalosporins, beta-lactams/ beta-lactamase inhibitors, aminoglycosides, fluoroquinolones and carbapenems
- Willing to join the study by signing a written informed consent form
Key exclusion criteria (4 listed)
- Pregnant or lactating woman
- Has contraindication for receiving tigecycline such as allergy to tetracycline
- Has received colistin for more than 24 hours
- Unable to receive tigecycline monotherapy
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 |
|---|---|---|
| TigecyclineAlso: Tygacil100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days. | Drug | Tigecycline |
Primary outcome
Effectiveness
Time frame: at the end of therapy (up to 28 days)
Clinical response is classified as cure, improvement, failure, relapse, death.
1 secondary outcome
Microbiological outcomes
Time frame: At the end of therapy (up to 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
Visanu Thamlikitkul, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tigecycline in people with Antibiotic Resistant Infection, run by Mahidol University at 1 site in Thailand.
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: status not confirmed, as of the sponsor's last update on 18 Jan 2012. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Visanu Thamlikitkul, MD (662-412-5994, sivth@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: at the end of therapy (up to 28 days)). It is what the study was designed to measure, not a finding.
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 18 Jan 2012.