Clinical trials: Intra-Abdominal Infections
Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
The purpose of this study is to learn about the safety and effectiveness of Zavicefta once released into the markets in Korea. This study is to learn about Zavicefta in patients with difficult types of infections in the abdomen…
- Conditions
- Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia
- Trial name
- NCT05733104
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Pfizer
Intra Abdominal Infections, Appendicitis Acute
Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
The NATURAL Study is a prospective, observational, pragmatic study of RNA biomarkers of infections to aid in the diagnosis of abdominal pain.
- Conditions
- Intra Abdominal Infections, Appendicitis Acute, Pyelonephritis, Diverticulitis
- Trial name
- NATURAL (NCT07579312)
- Testing
- TruNAV, an RNA-based blood test for host immune activation by infections
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- True Bearing Diagnostics, Inc.
Complicated Intra-abdominal Infections (cIAI)
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to <18 years with cIAI.
- Trial name
- NCT06794541
- Testing
- IV Eravacycline 2mg/kg, IV Eravacycline 1.5mg/kg
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Tetraphase Pharmaceuticals, Inc
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.
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, Urinary Tract Infections
Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts: Part 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of…
- Conditions
- Bacterial Infections, Urinary Tract Infections, Intra-Abdominal Infections, Respiratory Tract Infections
- Trial name
- NCT07207291
- Testing
- JKN2501
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia
Real-World Study of Ceftazidime Avibactam in China
This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.
- Conditions
- Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections
- Trial name
- REACT (NCT05487586)
- Testing
- ceftazidime avibactam group
- Where
- 17 sites in China
- Volunteers
- 220 people
- Sponsor
- Pfizer
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI)
- Trial name
- NCT07089186
- Testing
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram…
- Conditions
- Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia
- Trial name
- REVISIT (NCT03329092)
- Testing
- ATM-AVI, MTZ, MER
- Where
- 157 sites in United States, Argentina and 19 more
- Volunteers
- 422 people
- Sponsor
- Pfizer
Respiratory Tract Infections, Urinary Tract Infections
TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected…
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection
- Trial name
- SEPSIS-SHIELD (NCT04094818)
- Testing
- TriVerity
- Where
- 26 sites in United States, Greece
- Volunteers
- 1,441 people
- Sponsor
- Inflammatix
Urinary Tract Infection, Acute Pyelonephritis
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types…
- Conditions
- Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia
- Trial name
- NCT04882085
- Testing
- Zavicefta, Ceftazidime-Avibactam, Best Available Treatment
- Where
- 37 sites in China
- Volunteers
- 60 people
- Sponsor
- Pfizer
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 Intra-abdominal Infection
Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection
Study C3591036 is a Phase 3 study to assess the efficacy and safety of PF-06947386 in Japanese adult patients with complicated intra-abdominal infection requiring hospitalization.
- Trial name
- NCT04927312
- Testing
- PF-06947386, Metronidazole
- Where
- 29 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Pfizer
Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events.
- Conditions
- Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
- Trial name
- NCT01072539
- Testing
- tigecycline
- Where
- 36 sites in South Korea
- Volunteers
- 3,172 people
- Sponsor
- Pfizer
Respiratory Tract Infections, Urinary Tract Infections
Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)
This study aims to evaluate the diagnostic and prognostic performance of a novel mRNA diagnostic/prognostic classifier (interprets the expression of 29 host response mRNA biomarkers) from whole blood in adult patients presenting…
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection
- Trial name
- NCT05639504
- Testing
- IMX-BVN-4 and IMX-SEV-4
- Sponsor
- Inflammatix
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
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
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
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
Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections
This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult…
- Trial name
- NCT01265784
- Testing
- TP-434, Ertapenem
- Where
- 38 sites in United States, Bulgaria and 4 more
- Volunteers
- 143 people
- Sponsor
- Tetraphase Pharmaceuticals, Inc