EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.

Comparative Study of NXL103 versus Linezolid in adults with acute bacterial skin and skin structure infections (ABSSSI)

Research Site

A multicenter,investigator-blinded,randomized, comparative study to evaluate the efficacy and safety of oral NXL103 versus oral linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI)

Clinical outcome of cure at test of cure visit: clinically evaluable population. Cure is defined as those participants with complete and near-complete resolution (with no signs/symptom of active infection) of all signs and symptoms of ABSSSI present at baseline and the patient had received at least 5 days of the assigned treatment.

Clinical outcome of cure at the late follow-up visit: clinically evaluable population.  Cure is defined as those participants with complete and near-complete resolution (with no signs/symptom of active infection) of all signs and symptoms of ABSSSI present at baseline and the patient had received at least 5 days of the assigned treatment.

Clinical outcome of cure at the end of therapy: clinically evaluable population.  Cure is defined as those participants with complete and near-complete resolution (with no signs/symptom of active infection) of all signs and symptoms of ABSSSI present at baseline and the patient had received at least 5 days of the assigned treatment.

Microbiological outcome of success at test of cure visit: microbiologically evaluable population.  Success is defined as those participants with responses of eradication and presumptive eradication.

Clinically significant abnormal increases in the Alanine Aminotransferase (ALAT): safety population. Increases are defined as greater than 5 times the upper limit of normal.

Clinically significant abnormal increases in Aspartate Aminotransferase (ASAT)): safety population. Increases are defined as greater than 5 times the upper limit of normal.

Arms	Assigned Interventions
Experimental: NXL103 BID for 10-14 days orally	Drug: NXL103 BID for 10-14 days
Active Comparator: Linezolid BID for 10-14 days orally	Drug: Linezolid BID for 10-14 days

Comparative Study of NXL103 versus Linezolid in adults with acute bacterial skin and skin structure infections (ABSSSI)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator