Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-7625A · 2 trials · 6 indications
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at TOC (14 days post first dose). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10\^5 colony-forming unit (CFU)/mL were reduced to \<10\^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded.
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized.
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued during the study due to an AE was summarized.
The percentage of participants with clinical responses (cure, failure, or indeterminate) at TOC was determined. Clinical cure was defined as "complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required". Clinical failure was defined as "death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care". Indeterminate was defined as "study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure".
The percentage of participants with ≥1 AEs was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The percentage of participants withdrawing from study therapy due to an AE was determined.
| Arm | Type | Description |
|---|---|---|
| MK-7625A | EXPERIMENTAL | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. |
| MK-7625A + metronidazole | EXPERIMENTAL | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. |
| Name | Type | Description |
|---|---|---|
| MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) | DRUG | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion |
| metronidazole 500 mg | DRUG | metronidazole 500 mg administered as an IV infusion |
Inclusion Criteria: * Japanese males or females who need hospitalization * Clinical signs and/or symptoms of urinary tract infection (UTI) at screening visit, either one of the following: * Pyelonephritis (uncomplicated or complicated) * Complicated lower UTI (cUTI) * Has a pretreatment baseli...
MK-7625A is an investigational antibiotic combination developed by Merck & Company, Inc. (MRK) for treating serious bacterial infections. It is being studied in Phase 3 clinical trials for intra-abdominal infections and urinary tract infections, including complicated pyelonephritis. It is a small molecule therapeutic in the infectious disease area.
MK-7625A is being developed to treat complicated intra-abdominal infections and urinary tract infections, including complicated UTI and uncomplicated pyelonephritis. Clinical trials have enrolled adult participants aged 18 years and older. The program targets serious bacterial infections requiring antibiotic therapy in hospital and community settings.
MK-7625A is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is conducting the clinical development program for this antibiotic combination, including Phase 3 studies in Japanese participants with intra-abdominal and urinary tract infections.
MK-7625A is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Two Phase 3 trials have been completed, one in complicated intra-abdominal infection and one in complicated urinary tract infection and pyelonephritis, with a combined enrollment of 215 participants.
MK-7625A has been studied in two completed Phase 3 trials. NCT02739997 evaluated MK-7625A in combination with metronidazole in Japanese participants with complicated intra-abdominal infection, enrolling 100 participants. NCT02728089 evaluated MK-7625A in Japanese participants with uncomplicated pyelonephritis and complicated urinary tract infection, enrolling 115 participants.