Gram-Negative Bacterial InfectionsNCT03160040
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting
An observational study of Gram-Negative Bacterial Infections, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) at 6 sites in United States.
Trial summary
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-Negative Bacterial Infections
- What is being tested?
- Minocycline IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 71 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Oct 2017to 1 May 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in intensive care unit (ICU) and non-ICU real world settings throughout the United States, who received at least 48 hours of minocycline IV in the treatment of documented gram-negative infections.
Who may be able to join
- The participant was treated with Minocin IV for a presumed or culture-confirmed gram-negative infection, as monotherapy or part of a broader regimen, for at least 48 hours.
- The participant treatment for gram-negative infection was initiated May 1, 2015, or later.
- The participant was at least 18 years old.
- This was the first course of Minocin IV administered to the participant within the study period for the treatment of gram-negative infection.
- At least 60 days has elapsed since the participant received the last dose of Minocin IV therapy for a presumed or confirmed gram-negative infection (prior to data entry into the electronic case report form, including step-down to oral therapy.
Who cannot join
- The participant received Minocin IV as a part of a controlled clinical trial.
- The participant received Minocin IV as a part of a Medicines Company- or Rempex Company-sponsored pharmacoeconomic outcomes study.
- Pregnancy (in the participant's or participant's partner) occurred after the first dose of Minocin IV through hospital discharge.
- Female participants were pregnant or nursing at the time of enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Lee Memorial Health System
Fort Myers, Florida, 33901
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Florida Hospital Orlando
Orlando, Florida, 32803
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Infectious Disease and Pulmonary Consultant
Victoria, Texas, 77901
About this study
Official title: Retrospective, Observational Evaluation of the Utilization, Outcomes, and Adverse Events Associated With Minocin IV for the Treatment of Infections Presumed or Confirmed to be Caused by Gram-negative Bacteria in a Real World Setting
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
Read the detailed description
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
- Conditions
- Gram-Negative Bacterial Infections
- Being tested
- Minocycline IV
- Medical subject headings
- Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline IVDrug
Also called Minocin®
This study is an observational study. All participants were administered minocycline IV prior to enrollment in this study.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline IV | Participants who received 2 doses over 48 hours if given once daily or 4 doses over 48 hours if given twice daily of minocycline intravenous (IV) as monotherapy, with or without transition to oral minocycline. Receives: Drug: Minocycline IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV
The types of primary infections refers to only presumed or documented gram-negative bacterial infections.
Measured: Day 1
Infection-related Length Of Stay For Infections Being Treated With Minocycline IV
Data will be collected to include infection-related length of stay , which is defined as the difference between the day of initiation of antimicrobial administration for the primary infection and day of discontinuation, death, or discharge date, whichever is sooner. This may include minocycline IV or other empiric antimicrobial regimen.
Measured: Up to 30 days after minocycline IV infusion
Number Of Participants With A Microbiologic Response
The number of participants with a gram-negative pathogen for which minocycline IV is used for treatment of the primary infection site(s) and the number of participants with a gram-positive pathogen recovered from a secondary infection site or from a mixed culture also containing the targeted gram-negative pathogen will be presented.
Measured: Up to 30 days after minocycline IV infusion
Duration Of Treatment With Minocycline IV
The number of days of treatment with minocycline IV will be presented.
Measured: Day 1 through end of infusion with minocycline
Use Of Concomitant Antibiotics With Minocycline IV
Concomitant antibiotics include those used between the first and last dose of minocycline IV. The number of participants and the type of antibiotic taken will be presented.
Measured: Day 1 through end of infusion with minocycline
Proportion Of Participants With A Clinical Outcome Of Cure, Improved, Or Failure
Clinical assessments will be based on participant records between end of infusion to 30 days following the last dose of minocycline (includes minocycline IV plus oral minocycline). Clinical categories for assessment include:
- Cure: Clinical signs and symptoms are resolved and no additional antibiotic therapy is necessary for the treatment of the infection
- Improved: Partial resolution of clinical signs and symptoms and no additional antibiotic therapy is necessary for the treatment of the infection
- Failure: Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection
- Non-evaluable: Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure.
Measured: Up to 30 days after minocycline infusion
Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence
Microbiological assessments will be based on participant records between end of infusion to 30 days following the last dose of minocycline (includes minocycline IV plus oral minocycline). Microbiological categories will include only gram-negative pathogens believed to be related to the primary infection and are defined as:
- Eradication: Documentation of a negative bacterial culture from the same site as the initial positive baseline culture
- Presumed eradication: The absence of follow-up microbiological data/information in a participant with a clinical response of cure or improved
- Persistence: Bacterial growth from the same site as the initial positive baseline culture excluding colonization; also referred to as microbiologic failure.
Measured: Up to 30 days after minocycline infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start11 Oct 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Negative 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Information, Study director, Melinta Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160040
- Sponsor's protocol ID
- MDCO-MIN-16-05
- Status last verified
- Aug 2023
- First submitted
- 17 May 2017
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Observational Evaluation of the Utilization, Outcomes, and Adverse Events Associated With Minocin IV for the Treatment of Infections Presumed or Confirmed to be Caused by Gram-negative Bacteria in a Real World Setting
- ClinicalTrials.gov ID
- NCT03160040
- Acronym / sponsor ID
- MDCO-MIN-16-05
- Conditions
- Gram-Negative Bacterial Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 May 2017 (actual)
- 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.
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
Detailed description
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline IV | – | Drug: Minocycline IVParticipants who received 2 doses over 48 hours if given once daily or 4 doses over 48 hours if given twice daily of minocycline intravenous (IV) as monotherapy, with or without transition to oral minocycline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in intensive care unit (ICU) and non-ICU real world settings throughout the United States, who received at least 48 hours of minocycline IV in the treatment of documented gram-negative infections.
Key inclusion criteria (5 listed)
- The participant was treated with Minocin IV for a presumed or culture-confirmed gram-negative infection, as monotherapy or part of a broader regimen, for at least 48 hours.
- The participant treatment for gram-negative infection was initiated May 1, 2015, or later.
- The participant was at least 18 years old.
- This was the first course of Minocin IV administered to the participant within the study period for the treatment of gram-negative infection.
- At least 60 days has elapsed since the participant received the last dose of Minocin IV therapy for a presumed or confirmed gram-negative infection (prior to data entry into the electronic case report form, including step-down to oral therapy.
Key exclusion criteria (4 listed)
- The participant received Minocin IV as a part of a controlled clinical trial.
- The participant received Minocin IV as a part of a Medicines Company- or Rempex Company-sponsored pharmacoeconomic outcomes study.
- Pregnancy (in the participant's or participant's partner) occurred after the first dose of Minocin IV through hospital discharge.
- Female participants were pregnant or nursing at the time of enrollment.
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 |
|---|---|---|
| Minocycline IVAlso: Minocin®This study is an observational study. All participants were administered minocycline IV prior to enrollment in this study. | Drug | Minocycline IV |
Primary outcome
Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV
Time frame: Day 1
The types of primary infections refers to only presumed or documented gram-negative bacterial infections.
Infection-related Length Of Stay For Infections Being Treated With Minocycline IV
Time frame: Up to 30 days after minocycline IV infusion
Data will be collected to include infection-related length of stay , which is defined as the difference between the day of initiation of antimicrobial administration for the primary infection and day of discontinuation, death, or discharge date, whichever is sooner. This may include minocycline IV or other empiric antimicrobial regimen.
Number Of Participants With A Microbiologic Response
Time frame: Up to 30 days after minocycline IV infusion
The number of participants with a gram-negative pathogen for which minocycline IV is used for treatment of the primary infection site(s) and the number of participants with a gram-positive pathogen recovered from a secondary infection site or from a mixed culture also containing the targeted gram-negative pathogen will be presented.
Duration Of Treatment With Minocycline IV
Time frame: Day 1 through end of infusion with minocycline
The number of days of treatment with minocycline IV will be presented.
Use Of Concomitant Antibiotics With Minocycline IV
Time frame: Day 1 through end of infusion with minocycline
Concomitant antibiotics include those used between the first and last dose of minocycline IV. The number of participants and the type of antibiotic taken will be presented.
Proportion Of Participants With A Clinical Outcome Of Cure, Improved, Or Failure
Time frame: Up to 30 days after minocycline infusion
Clinical assessments will be based on participant records between end of infusion to 30 days following the last dose of minocycline (includes minocycline IV plus oral minocycline). Clinical categories for assessment include: * Cure: Clinical signs and symptoms are resolved and no additional antibiotic therapy is necessary for the treatment of the infection * Improved: Partial resolution of clinical signs and symptoms and no additional antibiotic therapy is necessary for the treatment of the infection * Failure: Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection * Non-evaluable: Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure.
Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence
Time frame: Up to 30 days after minocycline infusion
Microbiological assessments will be based on participant records between end of infusion to 30 days following the last dose of minocycline (includes minocycline IV plus oral minocycline). Microbiological categories will include only gram-negative pathogens believed to be related to the primary infection and are defined as: * Eradication: Documentation of a negative bacterial culture from the same site as the initial positive baseline culture * Presumed eradication: The absence of follow-up microbiological data/information in a participant with a clinical response of cure or improved * Persistence: Bacterial growth from the same site as the initial positive baseline culture excluding colonization; also referred to as microbiologic failure.
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 28 Aug 2023.
- Minocycline Intravenous for the Treatment of Serious Infections Due to Gram-Negative Nonpseudomonal Bacteria, Including Stenotrophomonas maltophilia, Acinetobacter baumannii, and Burkholderia cepaciaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Information study director
Melinta Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gram-Negative Bacterial Infections, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) at 6 sites in United States.
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 5 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
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?
Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV (time frame: Day 1). The study lists 7 primary outcomes in all. 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 28 Aug 2023.