Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections (DRESS)
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|ClinicalTrials.gov Identifier: NCT04042077|
Recruitment Status : Terminated (COVID-19 seriously affected the study execution as required by the protocol)
First Posted : August 1, 2019
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Drug: Delafloxacin Drug: Vancomycin Drug: Linezolid Drug: Piperacillin/Tazobactam Drug: Tigecycline||Phase 3|
This is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). IV to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (BAT) for either cardiothoracic/related leg or abdominal surgical site infection (SSI).
Approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or BAT. For patients who are randomised to BAT, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal SSI) as most appropriate for patient characteristics and local epidemiological pattern.
Duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per Investigator's judgment) followed by visits up to 30 days after end of treatment.
Patients will be hospitalized from Screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per Investigator's judgment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study will compare delafloxacin against best available therapy selected by the investigator for the cardiothoracic/leg related or abdominal site infection|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Only the blinded observer will be unaware of the treatment assigned to patient.|
|Official Title:||A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections|
|Actual Study Start Date :||September 25, 2019|
|Actual Primary Completion Date :||October 7, 2020|
|Actual Study Completion Date :||October 28, 2020|
Delafloxacin IV, with the option to switch to delafloxacin oral
Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
Active Comparator: Best Available Therapy
Cardiothoracic / related leg SSI
In case of suspicion of Gram-negative, additional therapy shall be added as per investigator's choice
In case of suspicion of MRSA, if the pre-selected treatment is Piperacillin/Tazobactam, additional therapy shall be added as per investigator's choice.
Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days
Solution for infusion or tablet, 600 mg BID, for 5 to 14 days
Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days
Powder for solution for infusion 50 mg, TID, for 5 to 14 days
- Clinical Success at Test Of Cure visit [ Time Frame: 7-14 days after last dose ]Clinical Success defined as the clinical response of "Cure" or "improved"
- Hospital Infection Related Length of Stay (IRLOS) [ Time Frame: up to 14 days ]Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
- Hospital Length of Stay (LOS) [ Time Frame: up to 45 days (Late Follow Up visit) ]Length of Stay since Screening till actual hospital discharge
- Eligibility to switch to oral formulation according to blinded observer's assessment [ Time Frame: up to 14 days ]Blinded assessment based on patient stabilization and ability to tolerate OS diet
- Microbiological response [ Time Frame: up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit) ]Documented or presumed eradication or persistence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042077
|Hospital Agostino Gemelli|
|Principal Investigator:||Stefano Margaritora||Hospital Agostino Gemelli|