Clinical trial • Not applicable • Infectious Disease
PIVMECILLINAM HYDROCHLORIDE for Gram-negative bacteremia
Not applicable trial of PIVMECILLINAM HYDROCHLORIDE for Gram-negative bacteremia.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Gram-negative bacteremia
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-07-2024
- First CTIS Authorization Date
- 25-07-2024
Trial design
Randomised, open-label, intervention arm: 5 days of antibiotic treatment. control arm: minimum of 7 days or more of antibiotic treatment. specific antibiotic choice is per local standard and multiple authorised antibiotics are permitted (examples listed in imps include: nitrofurantoin; trimethoprim; ciprofloxacin (oral and infusion formulations); piperacillin/tazobactam; meropenem; ertapenem; ampicillin; amoxicillin/clavulanic acid (bioclavid); ceftazidime; gentamicin (hexamycin); tobramycin (nebcina); sulfamethoxazole/trimethoprim; sulfametizol; selexid (pivmecillinam/mecillinam)). Not applicable trial across 7 sites in Denmark.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Intervention arm: 5 days of antibiotic treatment. Control arm: minimum of 7 days or more of antibiotic treatment. Specific antibiotic choice is per local standard and multiple authorised antibiotics are permitted (examples listed in IMPs include: Nitrofurantoin; Trimethoprim; Ciprofloxacin (oral and infusion formulations); Piperacillin/Tazobactam; Meropenem; Ertapenem; Ampicillin; Amoxicillin/clavulanic acid (Bioclavid); Ceftazidime; Gentamicin (Hexamycin); Tobramycin (Nebcina); Sulfamethoxazole/Trimethoprim; Sulfametizol; Selexid (pivmecillinam/mecillinam)).
- Target Sample Size
- 380
- Trial Duration For Participant
- 90
Eligibility
Recruits 380 No vulnerable population selected (isVulnerablePopulationSelected=false). Inclusion requires 'Oral and written informed consent' and only adults (Age >18 years) are eligible..
- Pregnancy Exclusion
- Pregnancy or breastfeeding
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Inclusion requires 'Oral and written informed consent' and only adults (Age >18 years) are eligible.
Inclusion criteria
- {"criterion_text":"- Age >18 years\n- Blood culture positive for Gram-negative bacteria\n- Evidence of urinary tract source of infection (positive urine culture or at least one clinical symptom compatible with urinary tract infection)\n- Antibiotic treatment with antimicrobial activity to Gram-negative bacteria administrated within 12 hours of first blood culture\n- Temperature <37.8°C at randomization\n- Clinically stabile at randomization (systolic blood pressure > 90 mm Hg, heart rate <100 beats/min., respiratory rate <24/minute, peripheral oxygen saturation > 90 %)\n- Oral and written informed consent"}
Exclusion criteria
- {"criterion_text":"- Antibiotic treatment (>2 day) with antimicrobial activity to Gram-negative bacteria within 14 days of inclusion\n- Gram-negative bacteremia within 30 days of blood culture\n- Immunosuppression (Untreated HIV-infection, Neutropenia (absolute neutrophil count < 1.0 x 109/l), Untreated terminal cancer, Receiving immunosuppressive agents (ATC-code L04A), Corticosteroid treatment (≥20 mg/day prednisone or the equivalent for >14 days) within the last 30 days, Chemotherapy within the last 30 days, Immunosuppressed after solid organ transplantation, Asplenia)\n- Polymicrobial growth in blood culture\n- Bacteremia with non-fermenting Gram-negative bacteria (Acinetobacter spp, Burkholderia spp, Pseudomonas spp), Brucella spp, or Fusobacterium spp\n- Failure to remove source of infection within 72 hours of first blood culture (e.g. change of catheter á demeure)\n- Pregnancy or breastfeeding"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 90-day survival without clinical or microbiological failure to treatment","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Mortality (timeframe 14, 30 and 90 days)\n- Total duration of antibiotic treatment (timeframe 90 days)\n- Type of antibiotic treatment (timeframe 90 days)\n- Duration of antibiotic treatment (timeframe 90 days)\n- Total length of hospital stay (timeframe 90 days)\n- Hospital re-admission\n- Antibiotic adverse events (timeframe 30 and 90 days)\n- Use of antimicrobials after discharge (timeframe 90 days)\n- Severe adverse events (timeframe 90 days)\n- Acute kidney injury (timeframe 90 days)\n- Clostridioides difficile infection - Number of participants with Clostridioides difficile infection (timeframe 90 days)\n- Multidrug-resistance organism: Multidrug-resistance organism defined as identification of resistant bacteria in a clinical specimen obtained only from a clinical infection. (timeframe 90 days)","definition_or_measurement_approach":"Timeframes provided in parentheses for applicable endpoints (e.g., mortality measured at 14, 30 and 90 days; antibiotic adverse events at 30 and 90 days; most others at 90 days). Multidrug-resistance organism defined as identification of resistant bacteria in a clinical specimen obtained only from a clinical infection."}
Recruitment
- Planned Sample Size
- 380
- Recruitment Window Months
- 78
- Consent Approach
- Oral and written informed consent is required from participants; only adults (Age >18 years) may consent. Subject information and informed consent form documents are listed (e.g., 'GNB5 Skriftlig deltagerinformation AHH'). No assent process or materials for under-18s are described. Languages of consent documents are not specified in the available data.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 380
Denmark
- Earliest CTIS Part Ii Submission Date
- 12-07-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 13
- Number Of Sites
- 7
- Number Of Participants
- 380
Sites
- Site Name
- Gentofte Hospital
- Department Name
- Infectious Diseases
- Contact Person Name
- Pernille Ravn
- Contact Person Email
- pernille.ravn@regionh.dk
- Site Name
- Hvidovre Hospital
- Department Name
- Infectious Diseases
- Contact Person Name
- Fatimah Al-Zergani
- Contact Person Email
- fatialz93@gmail.com
- Site Name
- Nordsjællands Hospital
- Department Name
- Infectious Diseases
- Contact Person Name
- Birgitte Lindegaard
- Contact Person Email
- birgitte.lindegaard.madsen@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Infectious Diseases
- Contact Person Name
- Isik Johansen
- Contact Person Email
- isik.somuncu.johansen@rsyd.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Infectious Diseases
- Contact Person Name
- Karina Frahm Kirk
- Contact Person Email
- kfk@rn.dk
- Site Name
- Herlev og Gentofte Hospital
- Department Name
- Infectious Diseases
- Contact Person Name
- Suzanne Lunding
- Contact Person Email
- suzanne.lunding01@regionh.dk
- Site Name
- Bispebjerg Hospital
- Department Name
- Infectious Diseases
- Contact Person Name
- Jesper Andreas Knudsen
- Contact Person Email
- jesper.andreas.knudsen@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Region Hovedstaden
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"Sponsor duties (code 1); contact email: gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Selexid
- Active Substance
- PIVMECILLINAM HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 09131)
- Maximum Dose
- 1200 mg per day
- Investigational Product Name
- Selexid
- Active Substance
- PIVMECILLINAM HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 45237)
- Maximum Dose
- 2400 mg per day
- Investigational Product Name
- Ciprofloxacin Fresenius Kabi
- Active Substance
- CIPROFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- IV INJECTION, IV INFUSION
- Route
- IV INJECTION, IV INFUSION
- Authorisation Status
- Authorised (marketingAuthNumber: 38748)
- Maximum Dose
- 800 mg per day
- Investigational Product Name
- Ampicillin "PCD"
- Active Substance
- AMPICILLIN
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION/INFUSION
- Authorisation Status
- Authorised (marketingAuthNumber: 06941 / 06940)
- Maximum Dose
- 8 g per day
- Investigational Product Name
- Meropenem "Stada"
- Active Substance
- MEROPENEM ANHYDROUS
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION OR INFUSION
- Route
- SOLUTION FOR INJECTION/INFUSION
- Authorisation Status
- Authorised (marketingAuthNumber: 48869 / 48870)
- Maximum Dose
- 1500 mg per day (or 3 g per day in some formulations)
- Investigational Product Name
- Sulfametizol ”Alternova”
- Active Substance
- SULFAMETHIZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 16510)
- Maximum Dose
- 2000 mg per day
- Investigational Product Name
- Selexid (solution for injection)
- Active Substance
- MECILLINAM
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- Authorised (marketingAuthNumber: 13525)
- Maximum Dose
- 3 g per day
- Investigational Product Name
- Bioclavid
- Active Substance
- AMOXICILLIN, CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 18925)
- Maximum Dose
- 1500 mg per day
- Investigational Product Name
- Piperacillin/Tazobactam "Stragen"
- Active Substance
- PIPERACILLIN, TAZOBACTAM
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- Authorised (marketingAuthNumber: 40525 / 40526)
- Maximum Dose
- 8 g to 16 g per day (product entries vary)
- Investigational Product Name
- Ciprofloxacin "HEXAL" (tablet)
- Active Substance
- CIPROFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 33094 / 33095 / 33096)
- Maximum Dose
- 1000-1500 mg per day depending on formulation
- Investigational Product Name
- Ciprofloxacin (infusion)
- Active Substance
- CIPROFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- IV INJECTION, IV INFUSION
- Route
- IV INJECTION, IV INFUSION
- Authorisation Status
- Authorised (marketingAuthNumber: 38748)
- Maximum Dose
- 800 mg per day (infusion product entry)
- Investigational Product Name
- Ceftazidim "Fresenius Kabi"
- Active Substance
- CEFTAZIDIME
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- Authorised (marketingAuthNumber: 42731)
- Maximum Dose
- 3 g per day
- Investigational Product Name
- Hexamycin (Gentamicin)
- Active Substance
- GENTAMICIN
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- Authorised (marketingAuthNumber: 11812)
- Maximum Dose
- 5 mg/Kg per day (as listed)
- Investigational Product Name
- Ertapenem Fresenius Kabi
- Active Substance
- ERTAPENEM SODIUM
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- Authorised (marketingAuthNumber: 57307)
- Maximum Dose
- 1 g per day
- Investigational Product Name
- Sulfametoxazol med trimetoprim SAD
- Active Substance
- SULFAMETHOXAZOLE, TRIMETHOPRIM
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 16511)
- Maximum Dose
- 1920 mg per day
- Investigational Product Name
- Nebcina (Tobramycin)
- Active Substance
- TOBRAMYCIN
- Modality
- Small molecule
- Routes Of Administration
- IV INJECTION, IV INFUSION
- Route
- IV INJECTION, IV INFUSION
- Authorisation Status
- Authorised (marketingAuthNumber: 06331)
- Maximum Dose
- 5 mg/Kg per day (product entry)
- Investigational Product Name
- Nitrofurantoin "EQL Pharma"
- Active Substance
- NITROFURANTOIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 7397)
- Maximum Dose
- 400 mg per day
- Investigational Product Name
- Trimopan
- Active Substance
- TRIMETHOPRIM
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketingAuthNumber: 09204)
- Maximum Dose
- 400 mg per day
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