Treatment Trials

83 Clinical Trials for Various Conditions

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SUSPENDED
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
Description

This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures

COMPLETED
Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants with Bacterial Pneumonia (XNW4107-302, REITAB-2)
Description

This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB, respectively). The primary hypothesis is that IMI-XNW4107 is non-inferior to IMI/REL in all-cause mortality.

COMPLETED
Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
Description

The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing regimen in the treatment of adults with CABP.

COMPLETED
Diagnostic and Prognostic Biomarkers for Childhood Bacterial Pneumonia
Description

Clinical pneumonia is a leading cause of pediatric hospitalization. The etiology is generally bacterial or viral. Prompt and optimal treatment of pneumonia is critical to reduce mortality. However, adequate pneumonia management is hampered by: a) the lack of a diagnostic tool that can be used at point-of-care (POC) and promptly and accurately allow the diagnosis of bacterial disease and b) lack of a prognostic POC test to help triage children in need of intensive assistance. Antibiotic therapy is frequently overprescribed as a result of suspected bacterial infections resulting in development of antibiotic resistance. Conversely, in malaria-endemic areas, antibiotics may also be "underprescribed" and children with bacterial pneumonia sent home without antibiotic therapy, when the clinical pneumonia is mistakenly attributed to a co-existing malaria infection. The investigators previously identified combinations of protein with 96% sensitivity and 86% specificity for detecting bacterial disease in Mozambican children with clinical pneumonia. The investigators' prior work showed that it is possible to identify biosignatures for diagnosis and prognosis using few proteins. Recently, other authors also identified different accurate biosignatures (e.g., IP-10, TRAIL and CRP). In this study, the investigators propose to validate and improve upon previous biosignatures by testing prior combinations and seeking novel combinations of markers in 900 pediatric inpatients aged 2 months to 5 years with clinical pneumonia in The Gambia. The investigators will also use alternative case criteria and seek diagnostic and prognostic combination of markers. This study will be conducted in Basse, rural Gambia, in two hospitals associated with the Medical Research Council Unity The Gambia (MRCG). Approximately 900 pediatric patients with clinical pneumonia aged 2 months to 5 years of age will be enrolled. Patients will undergo standard of care test and will have blood proteins measured through Luminex®-based immunoassays. Results of this study may ultimately support future development of an accurate point-of-care test for bacterial disease to guide clinicians in choices of treatment and to assist in the prioritization of intensive care in resource-limited settings.

TERMINATED
Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
Description

The primary purpose of the study is to determine the degree of penetration of cefiderocol into infected lung tissue in hospitalized adults with bacterial pneumonia who are being mechanically ventilated.

COMPLETED
Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia
Description

The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin in the treatment of adult patients with community-acquired pneumonia.

TERMINATED
Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
Description

This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).

COMPLETED
A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia
Description

This study is a randomized, open-label phase I study. The primary objective of this study is to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically ventilated bacterial pneumonia (MVBP). The secondary objective of this study is to assess the safety and tolerability of ME1100 for the treatment of subjects with MVBP to assess the safety and tolerability of ME1100.

WITHDRAWN
A P3 Comparator Trial in Community Acquired Bacterial Pneumonia
Description

This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.

COMPLETED
Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
Description

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

COMPLETED
Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
Description

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

COMPLETED
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
Description

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Conditions
COMPLETED
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
Description

This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

COMPLETED
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
Description

This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.

TERMINATED
Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
Description

The purpose of this study is to determine the efficacy, safety and tolerability of JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization for Community-Acquired Bacterial Pneumonia (CABP).

COMPLETED
Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
Description

Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.

TERMINATED
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
Description

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with pneumonia.

WITHDRAWN
Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children
Description

The purpose of this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.

COMPLETED
A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia
Description

This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

COMPLETED
Phase II Study of Oral Nafithromycin in CABP
Description

Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

COMPLETED
Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Description

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.

COMPLETED
Telavancin Observational Use Registry (TOUR)
Description

The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.

COMPLETED
Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia
Description

Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics together. These antibiotics usually include a cephalosporin and a macrolide. The most commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline. This research is being done to find out how well a new cephalosporin antibiotic, called ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in hospitalized patients based on two research studies. In one study, ceftaroline was better than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone. Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe as ceftriaxone.

TERMINATED
Clinical Trials to Reduce the Risk of Antimicrobial Resistance
Description

The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).

COMPLETED
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
Description

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

COMPLETED
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
Description

The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

COMPLETED
Study of Fluid Collection of the Chest in Children With Pneumonia
Description

The purpose of this study is to determine the best treatment for children with a fluid collection in the chest associated with an underlying pneumonia. Researchers generally agree that a child with a large fluid collection in the chest need to have the fluid drained in addition to anitbiotics. There have been many treatments studied in children that have been shown to be effective and safe, but the treatments have never been compared to each other in a randomized controlled study. The optimal treatment of pediatric parapneumonic effusions remains controversial. The objective of this study is to compare the use of conventional management (antibiotics with thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis is that pediatric patients with parapneumonic effusion, regardless of pleural fluid composition and loculations, have decreased morbidity when treated with early thoroscopic adhesiolysis (VATS) compared with conservative treatment.

COMPLETED
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Description

Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

COMPLETED
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
Description

To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.

TERMINATED
A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101
Description

CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunct therapy with standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in healthy volunteers followed by a similar assessment in patients with suspected or confirmed community acquired bacterial pneumonia of moderate severity. The main questions the study aims to answer are: * Are single ascending doses of a CMTX-101 intravenous (IV) infusion safe and tolerated * What is the pharmacokinetic (PK) profile of single-ascending doses CMTX 101 * Do single ascending doses of CMTX 101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs) Exploratory efficacy biomarkers will also be measured in the patient part of the study. Participants will be administered a single IV infusion of CMTX-101 over a 60-minute period; patients will receive the infusion after starting standard of care antibiotics.