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This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline IV | Drug | This study is an observational study. All participants were administered minocycline IV prior to enrollment in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Day 1 through end of infusion with minocycline |
| Proportion Of Participants With A Clinical Outcome Of Cure, Improved, Or Failure |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Information | Melinta Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lee Memorial Health System | Fort Myers | Florida | 33901 | United States | ||
| Florida Hospital Orlando |
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| Label | URL |
|---|---|
| Minocycline Intravenous for the Treatment of Serious Infections Due to Gram-Negative Nonpseudomonal Bacteria, Including Stenotrophomonas maltophilia, Acinetobacter baumannii, and Burkholderia cepacia | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| MINOCINĀ® (minocycline) | Package Insert | View IPD |
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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:
|
| 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:
| Up to 30 days after minocycline infusion |
| Orlando |
| Florida |
| 32803 |
| United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| Infectious Disease and Pulmonary Consultant | Victoria | Texas | 77901 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
MINOCINĀ® (minocycline) for Injection 100 mg/vial. United States Prescribing Information. |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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