A Phase 3 interventional study of ceftobiprole medocaril and IV standard-of-care cephalosporin in Community-acquired Pneumonia (CAP) and Hospital-acquired Pneumonia (HAP), sponsored by Basilea Pharmaceutica. Completed at 19 sites in 4 countries. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by Basilea Pharmaceutica · Phase 3, Interventional, and Treatment
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Among 11 studies in Community-Acquired Pneumonia with a site in Hungary — 2 open to participants now, 2 under way, 2 of them phase 3. Community-Acquired Pneumonia · Hungary.
Among the 11 studies in Community-Acquired Pneumonia with a site in Hungary, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2017, is one of 9 in phase 3, and was the 8th registered.
325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.
Browse Community-Acquired Pneumonia studies →2 of the 11 studies in Community-Acquired Pneumonia with a site in Hungary are open now. Recruiting first, the newest first:
Biotest · Sites in Hungary, United States, Argentina and 15 more countries
Ages 18+
UMC Utrecht · Sites in Hungary, United States, Australia and 26 more countries
Ages 28 days+
A study can be open while its sites in Hungary have not opened yet or have stopped. Only those recruiting at a site in Hungary →
Of the 41 Community-Acquired Pneumonia studies recruiting now, 29 (71%) set no upper age limit and 9 (22%) stop at 75 or younger; 13 take children under 18; 5 take healthy volunteers.
This study: 3 Months to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 10
First in 2007; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 138 is below the median of 246 across 196 interventional studies indexed under Community-Acquired Pneumonia.
Median enrollment 598 across the 10 interventional studies, 2,595 across the 1 observational. Of the 9 that completed or were terminated, 6 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 11 have an industry lead sponsor. The 7 most frequent:
Basilea Pharmaceutica is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Basilea Pharmaceutica has 2 studies filed under Community-Acquired Pneumonia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Community-Acquired Pneumonia with a site in Hungary, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring intravenous (IV) antibiotic therapy.
This was a randomized, investigator-blind, active-controlled multi-center study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole medocaril compared with IV standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients aged 3 months to less than 18 years with HAP or CAP requiring hospitalization and therapy with IV antibiotics. Randomization was stratified by four age groups (3 months to \< 2 years; 2 years to \< 6 years; 6 years to \< 12 years; 12 years to \< 18 years), and by diagnosis of HAP or CAP.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for IV administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
Drug: ceftobiprole medocaril
Ceftriaxone was used as standard-of-care cephalosporin for the treatment of CAP. It is a third-generation cephalosporin with activity against typical bacterial pathogens of CAP requiring hospitalization, and is widely used for the treatment of various bacterial infections in neonates, infants, children, and adults. Ceftazidime was used as standard-of-care cephalosporin for the treatment of HAP. It is also a third-generation cephalosporin, but with broader activity against Gram-negative aerobic bacilli, including Pseudomonas aeruginosa. Vancomycin is a glycopeptide antibiotic that is active against staphylococci, including methicillin-resistant Staphylococcus aureus (MRSA). At the discretion of the blinded investigator, patients received vancomycin in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed.
Drug: IV standard-of-care cephalosporin
Ceftobiprole medocaril was administered at age-adjusted doses (10, 15 or 20 mg/kg) and infusion durations (2 or 4 hours) every 8 hours. The maximum dose, regardless of body weight, was 500 mg ceftobiprole every 8 hours (maximum total daily dose of 1500 mg ceftobiprole). After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.
Also known as: ceftobiprole
Ceftriaxone was administered at 50 to 80 mg/kg IV as a single daily dose, up to a maximum dose of 2 g/day. The actual dose of ceftriaxone within this dose range was determined by the blinded investigator prior to first study drug administration and was not modified during subsequent study days. After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment. At the discretion of the blinded investigator, patients received vancomycin at a dose of 10 to 15 mg/kg IV every 6 hours, up to a maximum dose of 2 g/day, in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed.
Adverse Events
Reported are adverse events (AEs) during the first 3 days of IV therapy and while patients were on IV therapy irrespective of when they switched to oral antibiotic treatment.
Time frame: Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days
Proportion of Patients With Clinical Cure in the Intent-to-treat Population (ITT)
Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the ITT population between ceftobiprole and the comparator at the TOC visit.
Time frame: At the test-of-cure (TOC) visit
Proportion of Patients With Clinical Cure in the Clinically Evaluable (CE) Population
Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the CE population between ceftobiprole and the comparator at the TOC visit.
Time frame: At the TOC visit
Proportion of Patients With Early Clinical Response in the Intent-to-treat (ITT) Population
Comparison of early clinical response rates in the ITT population between ceftobiprole and the comparator at Day 4.
Time frame: At Day 4
Proportion of Patients With Early Clinical Response in the Clinically Evaluable (CE) Population
Comparison of early clinical response rates in the CE population between ceftobiprole and the comparator at Day 4.
Time frame: At Day 4
| Milestone | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| Started | 94 | 44 |
| Completed | 90 | 44 |
| Not completed | 4 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Other reasons | 1 | 0 |
Reported are adverse events (AEs) during the first 3 days of IV therapy and while patients were on IV therapy irrespective of when they switched to oral antibiotic treatment.
| Participants | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| First 3 days of IV therapy — Non-Serious TEAE | 10 | 5 |
| First 3 days of IV therapy — Serious TEAE | 1 | 0 |
| First 3 days of IV therapy — TEAE leading to death | 0 | 0 |
| First 3 days of IV therapy — No TEAE | 83 | 39 |
| While on IV therapy — Non-Serious TEAE | 17 | 8 |
| While on IV therapy — Serious TEAE | 2 | 0 |
| While on IV therapy — TEAE leading to death | 0 | 0 |
| While on IV therapy — No TEAE | 75 | 36 |
Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the ITT population between ceftobiprole and the comparator at the TOC visit.
| Participants | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| Proportion of Patients With Clinical Cure in the Intent-to-treat Population (ITT) | 85 | 43 |
Comparison of clinical cure rates (signs and symptoms of pneumonia normalized or improved such that no further antibiotic therapy was necessary, and stabilization or improvement of chest X-ray findings if these were available) in the CE population between ceftobiprole and the comparator at the TOC visit.
| Participants | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| Proportion of Patients With Clinical Cure in the Clinically Evaluable (CE) Population | 80 | 41 |
Comparison of early clinical response rates in the ITT population between ceftobiprole and the comparator at Day 4.
| Participants | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| Proportion of Patients With Early Clinical Response in the Intent-to-treat (ITT) Population | 90 | 41 |
Comparison of early clinical response rates in the CE population between ceftobiprole and the comparator at Day 4.
| Participants | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| Proportion of Patients With Early Clinical Response in the Clinically Evaluable (CE) Population | 84 | 39 |
Collected over Relevant worsening of a patient's status after informed consent (before start of first study-drug infusion) was recorded in medical history. From start of first dosing to and including the last follow-up visit, 28 to 35 days after end-of-treatment, such worsening was recorded as an AE.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ceftobiprole Medocaril | 0/94 (0%) | 7/94 (7.4%) | 8/94 (8.5%) |
| IV Standard-of-care Cephalosporin | 0/44 (0%) | 2/44 (4.5%) | 5/44 (11.4%) |
| Event | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| PneumoniaInfections and infestations | 3/94 | 0/44 |
| Seizure like phenomenaNervous system disorders | 0/94 | 1/44 |
| BronchitisInfections and infestations | 0/94 | 1/44 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/94 | 0/44 |
| PleurisyRespiratory, thoracic and mediastinal disorders | 1/94 | 0/44 |
| HypersensitivityImmune system disorders | 1/94 | 0/44 |
| VomitingGastrointestinal disorders | 1/94 | 0/44 |
| Pharyngitis streptococcalInfections and infestations | 1/94 | 0/44 |
| Tonsillitis streptococcalInfections and infestations | 1/94 | 0/44 |
| Event | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 2/94 | 4/44 |
| VomitingGastrointestinal disorders | 6/94 | 1/44 |
| Age, Categorical(Participants) | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin | Total |
|---|---|---|---|
| <=18 years | 94 | 44 | 138 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin | Total |
|---|---|---|---|
| Mean | 6.81 (0.6 to 17) | 6.95 (1 to 17) | 6.86 (0.6 to 17) |
| Sex: Female, Male(Participants) | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin | Total |
|---|---|---|---|
| Female | 41 | 23 | 64 |
| Male | 53 | 21 | 74 |
| Race (NIH/OMB)(Participants) | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 94 | 43 | 137 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Infection type(Participants) | Ceftobiprole Medocaril | IV Standard-of-care Cephalosporin | Total |
|---|---|---|---|
| Hospital-acquired pneumonia | 5 | 3 | 8 |
| Community-acquired pneumonia | 89 | 41 | 130 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Mar 2020, 27 months.
Results were first posted in Sep 2020, 5 months after primary completion.
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Studies of the drug tested here: Ceftobiprole medocaril
Community-Acquired Pneumonia →