Clinical trials: Complicated Intra-abdominal Infection
Intra Abdominal Infections
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by…
- Trial name
- NCT03358576
- Testing
- Ertapenem, Sulopenem-Etzadroxil/Probenecid, Ciprofloxacin
- Where
- 42 sites in United States, Bulgaria and 5 more
- Volunteers
- 674 people
- Sponsor
- Iterum Therapeutics, International Limited
Complicated Intra-Abdominal Infections, cIAIs, Hospital-acquired Pneumonia (HAP)
Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE
Why This Study is Needed Some bacterial infections have become resistant to common antibiotics, making them very difficult to treat. This is a growing and serious health problem.
- Conditions
- Complicated Intra-Abdominal Infections, cIAIs, Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
- Trial name
- AWARE (NCT07268560)
- Testing
- Aztreonam-Avibactam
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Sir Run Run Shaw Hospital
Crohn's Disease
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
The goal of this observational study is to evaluate the effectiveness and safety of exclusive enteral nutrition (EEN) in adults with active Crohn's disease (CD), particularly in patients with complicated disease such as…
- Trial name
- EEN-CD (NCT07504510)
- Testing
- Exclusive Enteral Nutrition
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Urinary Tract Infection Complicated, Acute Pyelonephritis
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02168946
- Testing
- Vabomere, Best Available Therapy
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 77 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Complicated Intra-abdominal Infection
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
- Trial name
- RECLAIM3 (NCT01726023)
- Testing
- Ceftazidime-avibactam, metronidazole, Meropenem
- Where
- 30 sites in China, South Korea and 1 more
- Volunteers
- 486 people
- Sponsor
- Pfizer
Infections, Pelvic Infections
An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)
The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute…
- Trial name
- NCT00092170
- Testing
- MK0826, ertapenem sodium, Comparator: Ticarcillin/Clavulanate
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Complicated Intraabdominal Infections
CABI: Antibiotic Duration for Complicated Intra-ABdominal Infection
Complicated intra-ABdominal Infections (CABIs) are abdominal infections where there is an abscess inside the abdomen, or a hole (perforation) in an abdominal organ such that infected material e.g.
- Trial name
- CABI (NCT03265834)
- Testing
- < 10 days of antibiotics, 28 days of antibiotics
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- University of Leeds
Intra-abdominal Infections
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with…
- Trial name
- NCT06633718
- Testing
- Meropenem and Pralurbactam, Saline, Ceftazidime-avibactam
- Where
- China
- Volunteers
- 786 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Complicated Urinary Tract Infection, Acute Pyelonephritis
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
This study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the…
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- Integral-2 (NCT05905055)
- Testing
- co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, BAT
- Where
- 54 sites in China, Croatia and 12 more
- Volunteers
- 126 people
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Necrotizing Enterocolitis, Intra-abdominal Infection
Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known.
- Trial name
- NCT00621192
- Testing
- meropenem
- Where
- 26 sites in United States
- Volunteers
- 200 people
- Sponsor
- The Emmes Company, LLC
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Bacterial Infections and Mycoses, Appendicitis
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.
- Conditions
- Bacterial Infections and Mycoses, Appendicitis, Cholecystitis, Pancreatitis
- Trial name
- NCT00229060
- Testing
- doripenem
- Volunteers
- 483 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Complicated Intra-abdominal Infections
Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
This study aims to evaluate the efficacy of ceftolozane/tazobactam (MK-7625A) plus metronidazole versus meropenem in adults diagnosed with complicated intra-abdominal infection (cIAI).
- Trial name
- 7625ACNPhase3 (NCT03830333)
- Testing
- Ceftolozane/Tazobactam, Metronidazole, Meropenem
- Where
- 25 sites in China
- Volunteers
- 268 people
- Sponsor
- Merck Sharp & Dohme LLC
Intraabdominal Infections
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to <18 years old.
- Trial name
- MOXIPEDIA (NCT01069900)
- Testing
- Moxifloxacin (Avelox, BAY12-8039), Ertapenem, Amoxicillin/Clavulanate
- Where
- 39 sites in United States, Argentina and 14 more
- Volunteers
- 458 people
- Sponsor
- Bayer
Complicated Intra-Abdominal Infections
Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections
The objectives of the study were: 1. To study risk factors for colonization and infection with antibiotic resistant bacteria among patients with severe IAI before and after antibiotic treatment and surgical intervention. 2.
- Trial name
- Bakki (NCT00860587)
- Volunteers
- 200 people
- Sponsor
- University Hospital, Linkoeping
Complicated Intra-abdominal Infection
Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults…
- Trial name
- NCT01445678
- Testing
- CXA-201 and metronidazole, Meropenem
- Where
- 61 sites in United States, Argentina and 13 more
- Volunteers
- 494 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Complicated Intra-abdominal Infections
Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated…
- Trial name
- IGNITE1 (NCT01844856)
- Testing
- Eravacycline, Ertapenem
- Where
- 69 sites in United States, Argentina and 11 more
- Volunteers
- 541 people
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Complicated Intra-Abdominal Infection
MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.
- Trial name
- NCT03217136
- Testing
- Ceftolozane/Tazobactam, Metronidazole, Meropenem
- Where
- 50 sites in United States, Brazil and 10 more
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Pneumonia, Ventilator-Associated, Pneumonia, Bacterial
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection.
- Conditions
- Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Pneumonia, Abdominal Abscess
- Trial name
- NCT00515034
- Testing
- Imipenem/cilastatin, Doripenem
- Volunteers
- 146 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Secondary Peritonitis, Abscess, Intra-Abdominal
Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is…
- Trial name
- NCT01096511
- Testing
- Moxifloxacin (Avelox, BAY12-8039)
- Where
- China
- Volunteers
- 1,001 people
- Sponsor
- Bayer