Clinical trial • Phase IV • Infectious Disease

DELAFLOXACIN for Pseudomonas aeruginosa bacteremia

Phase IV trial of DELAFLOXACIN for Pseudomonas aeruginosa bacteremia.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Pseudomonas aeruginosa bacteremia
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-06-2024
First CTIS Authorization Date
08-07-2024

Trial design

Randomised, open-label, multiple standard-of-care comparator antibiotic arms are used (products listed in ctis): ciprofloxacino aurovitas 750 mg (ciprofloxacin, oral); cefepime accord 1 g (cefepime, iv); quofenix 300 mg (delafloxacin, iv); colistimetato de sodio accord 2 million iu (colistimethate sodium, iv); tobramicina normon 100 mg/2 ml (tobramycin, iv); zerbaxa 1 g/0.5 g (ceftolozane/tazobactam, iv); quofenix 450 mg tablets (delafloxacin, oral); azactam 1 g (aztreonam, iv); ciprofloxacino kabi 2 mg/ml (ciprofloxacin, iv); levofloxacino normon 500 mg (levofloxacin, oral); fetcroja 1 g (cefiderocol, iv); amikacine b. braun 2.5 mg/ml (amikacin, iv); zavicefta 2 g/0.5 g (ceftazidime/avibactam, iv); vaborem 1 g/1 g (meropenem/vaborbactam, iv); imipenem/cilastatina aurovitas 500/500 mg (imipenem/cilastatin, iv); piperacilina/tazobactam accord 4 g/0.5 g (piperacillin/tazobactam, iv); ceftazidima sala 1.000 mg (ceftazidime, iv); meropenem qilu 1 g (meropenem, iv). doses shown in ctis part i are maximum daily amounts; explicit dosing schedules are not specified in the ctis record.-controlled Phase IV trial in Spain.

Randomised
Yes
Open Label
Yes
Comparator
Multiple standard-of-care comparator antibiotic arms are used (products listed in CTIS): Ciprofloxacino Aurovitas 750 mg (ciprofloxacin, oral); CEFEPIME ACCORD 1 g (cefepime, IV); Quofenix 300 mg (delafloxacin, IV); Colistimetato de sodio Accord 2 million IU (colistimethate sodium, IV); Tobramicina NORMON 100 mg/2 ml (tobramycin, IV); Zerbaxa 1 g/0.5 g (ceftolozane/tazobactam, IV); Quofenix 450 mg tablets (delafloxacin, oral); Azactam 1 g (aztreonam, IV); CIPROFLOXACINO KABI 2 mg/ml (ciprofloxacin, IV); LEVOFLOXACINO NORMON 500 mg (levofloxacin, oral); Fetcroja 1 g (cefiderocol, IV); AMIKACINE B. BRAUN 2.5 mg/ml (amikacin, IV); Zavicefta 2 g/0.5 g (ceftazidime/avibactam, IV); Vaborem 1 g/1 g (meropenem/vaborbactam, IV); Imipenem/Cilastatina Aurovitas 500/500 mg (imipenem/cilastatin, IV); Piperacilina/Tazobactam Accord 4 g/0.5 g (piperacillin/tazobactam, IV); Ceftazidima SALA 1.000 mg (ceftazidime, IV); MEROPENEM QILU 1 g (meropenem, IV). Doses shown in CTIS Part I are maximum daily amounts; explicit dosing schedules are not specified in the CTIS record.
Target Sample Size
306
Trial Duration For Participant
90

Eligibility

Recruits 306 Vulnerable populations are not selected for inclusion. Minors are explicitly excluded (participants must be adults 18+). Participants must have signed informed consent; no paediatric assent procedures are applicable..

Pregnancy Exclusion
Pregnant or breastfeeding women. Potentially fertile patients must have a negative pregnancy test.
Vulnerable Population
Vulnerable populations are not selected for inclusion. Minors are explicitly excluded (participants must be adults 18+). Participants must have signed informed consent; no paediatric assent procedures are applicable.

Inclusion criteria

  • {"criterion_text":"- Adult patients (18 years or older).\n- Present bacteremia due to P. aeruginosa.\n- Having received 6 days (+/-1) of active antibiotic treatment against bacteremia counted from the date of extraction of the first positive blood culture and until the moment of randomization.\n- Have signed the informed consent for the trial."}

Exclusion criteria

  • {"criterion_text":"- Minors under 18 years of age.\n- Polymicrobial bacteremia including microorganisms other than P. aeruginosa. Polymicrobial bacteremia is considered the isolation in blood of more than one bacteria other than P.aeruginosa with clinical significance. P.aeruginosa bacteremias that are accompanied by isolates considered as contaminations (coagulase-negative staphylococci or viridans group streptococci, etc.) without clinical significance can be recruited for the trial, since these will not require specific treatment, and should not be considered polymicrobial bacteremia for the purposes of the assay.\n- Patients in palliative care or with an expected survival of less than 48 hours at the time of randomization.\n- Bacteremia due to P. aeruginosa in the previous 30 days as long as the previous infection has not been resolved.\n- The doctor responsible for the patient does not want to include the patient in the clinical trial.\n- Pregnant or breastfeeding women. Potentially fertile patients must have a negative pregnancy test.\n- Focus of bacteremia not adequately controlled at least 72 hours before randomization.\n- Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment, greater than 7 days, including: -Post-obstructive or necrotizing pneumonia. -Lung abscesses. -Acute prostatitis. -Bone and joint infections. -Central nervous system infections. -Endovascular infections related to vascular prostheses. -Any other at the discretion of the doctor responsible for the patient.\n- Coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment if their treatment will be extended beyond 7 days from the diagnosis of bacteremia by P. aeruginosa. On the contrary, in the event that an infection coexists whose treatment ends before randomization, the patient may be included. Also in case there are isolates other than P. aeruginosa in samples corresponding to colonizations that do not require antibiotic treatment (asymptomatic bacteriuria, contamination of blood cultures by colonizers usual, bronchoaspirates without symptoms or signs suggestive of infection respiratory), the patient may be included in the trial..\n- Bacteremic pneumonia in severely immunocompromised patients, defined as: -Patients with severe neutropenia (<500 cells/mm3). -Recipients of allogeneic hematopoietic stem cell or solid organ transplant, during the first year after the transplant. -Active graft-versus-host disease requiring immunosuppressive treatment. -Patients with solid tumors who are receiving chemotherapy. -Untreated HIV infection with CD4 < 200 cells/mm3. -Patients with primary combined immunodeficiency. -Steroid treatment with prednisone > 20 mg/day (or equivalent) for 14 days prior to randomization.\n- Bacteremia of any origin in patients with severe neutropenia (<500 cells/mm3) at the time of randomization.\n- Bacteremia of any origin in large burns.\n- Bacteremia produced by strains resistant to all beta-lactams and quinolones."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Days of antibiotic treatment and DOOR scale category (Desirability of Outcome Ranking) at the end of follow-up: Day +30 after the end of aproppriate antibiotic treatment.","definition_or_measurement_approach":"Measured at Day +30 after the end of appropriate antibiotic treatment; endpoints capture total days of antibiotic exposure and DOOR category at end of follow-up."}

Secondary endpoints

  • {"endpoint_text":"- All-cause mortality, clinical cure and treatment failure: Days +30 and +90 after the end of aproppriate antibiotic treatment.\n- Superinfections, serious adverse events, days of hospital stay, and recurrences (proven, probable or possible): Day +90 after the end of aproppriate antibiotic treatment.","definition_or_measurement_approach":"All-cause mortality, clinical cure and treatment failure assessed at Day +30 and Day +90 after end of appropriate antibiotic treatment. Superinfections, serious adverse events, hospital stay duration and recurrences assessed up to Day +90 after end of appropriate antibiotic treatment."}

Recruitment

Planned Sample Size
306
Recruitment Window Months
40
Consent Approach
Participants must be adults (18+) and provide written informed consent. The CTIS record lists a subject information and informed consent form document (L1_SIS and ICF adults). No paediatric assent procedures (minors are excluded).

Geography

Total Number Of Sites
37
Total Number Of Participants
306

Spain

Earliest CTIS Part Ii Submission Date
25-09-2023
Latest Decision Or Authorization Date
25-07-2025
Processing Time Days
669
Number Of Sites
37
Number Of Participants
306

Sites

Site Name
Hospital Universitario De Burgos
Department Name
infectious diseases
Contact Person Name
Carolina Navarro San Francisco
Contact Person Email
carolinansf@yahoo.es
Site Name
Parc Tauli Hospital Universitari
Department Name
infectious diseases
Contact Person Name
Aina Gomila Grange
Contact Person Email
agomilagrange@gmail.com
Site Name
Hospital San Pedro
Department Name
infectious diseases
Contact Person Name
Jorge Alba Fernández
Contact Person Email
jorge.alba.fdez@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
infectious diseases
Contact Person Name
Idoia Bilbao del Olmo
Contact Person Email
ibilbaodelolmo@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
infectious diseases
Contact Person Name
Ibai Los Arcos Bertiz
Contact Person Email
ibai.losarcos@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
infectious diseases
Contact Person Name
Luis Eduardo López Cortés
Contact Person Email
luiselopezcortes@gmail.com
Site Name
Hospital De Jerez De La Frontera
Department Name
infectious diseases
Contact Person Name
Antonio Jesús Hidalgo Castellón
Site Name
Hospital Universitario De Jaen
Department Name
infectious diseases
Contact Person Name
Carmen Herrero Rodríguez
Contact Person Email
gonees.data@hotmail.es
Site Name
Hospital Universitario Torrecardenas
Department Name
infectious diseases
Contact Person Name
María Ángeles Esteban Moreno
Contact Person Email
mariaa.esteban.moreno.sspa@juntadeandalucia
Site Name
Hospital Universitario Central De Asturias
Department Name
Medicina Intensiva
Contact Person Name
Emilio García Prieto
Contact Person Email
egarciaprieto@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
infectious diseases
Contact Person Name
María Carmen Fariñas Álvarez
Contact Person Email
farinasc@unican.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medicina intensiva
Contact Person Name
Paula Ramírez Galleymore
Contact Person Email
ramirez_pau@gva.es
Site Name
Hospital Universitario De Puerto Real
Department Name
infectious diseases
Contact Person Name
Patricia Jiménez Aguilar
Contact Person Email
patriciajaguilar@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
infectious diseases
Contact Person Name
Miguel Ángel López Zúñiga
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
infectious diseases
Contact Person Name
Elisabet Petkova Saiz
Contact Person Email
elipetsaiz@yahoo.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
infectious diseases
Contact Person Name
María del Rocío Álvarez Marín
Contact Person Email
rocioalma@gmail.com
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
infectious diseases
Contact Person Name
Adrián Sousa Domínguez
Contact Person Email
asousadominguez@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
infectious diseases
Contact Person Name
Joaquín López-Contreras González
Contact Person Email
jlcontreras@santpau.cat
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Microbiología
Contact Person Name
Fátima Galán Sánchez
Contact Person Email
fatima.galan@uca.es
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
infectious diseases
Contact Person Name
María Franco Huerta
Contact Person Email
marifranki@hotmail.com
Site Name
Hospital Universitario Lucus Augusti
Department Name
infectious diseases
Contact Person Name
Eva María Romay Lema
Contact Person Email
eva.maria.romay.lema@gmail.com
Site Name
Hospital Costa Del Sol
Department Name
infectious diseases
Contact Person Name
Alfonso del Arco Jiménez
Contact Person Email
alfarco@gmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
infectious diseases
Contact Person Name
Francisco Anguita Santos
Contact Person Email
fanguitasantos@gmail.com
Site Name
University Hospital Son Espases
Department Name
infectious diseases
Contact Person Name
Helem Haydeé Vilchez Rueda
Contact Person Email
helem.vilchez@ssib.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
infectious diseases
Contact Person Name
Pilar Martín Dávila
Contact Person Email
pmartind@salud.madrid.org
Site Name
Hospital General Universitario De Valencia
Department Name
infectious diseases
Contact Person Name
Vicente Abril López de Medrano
Contact Person Email
abril_viclop@gva.es
Site Name
Hospital Universitario Reina Sofia
Department Name
infectious diseases
Contact Person Name
Juan José Castón Osorio
Contact Person Email
juanjoco2005@yahoo.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
infectious diseases
Contact Person Name
Esperanza Merino de Lucas
Contact Person Email
merino_luc@gva.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
infectious diseases
Contact Person Name
Juan Diego Ruiz Mesa
Contact Person Email
jdruizmesa@hotmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
infectious diseases
Contact Person Name
María Dolores Sousa Regueiro
Contact Person Email
dsoureg@sergas.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
infectious diseases
Contact Person Name
José Ramón Paño Pardo
Contact Person Email
joserrapa@gmail.com
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Microbiología e Inmunología
Contact Person Name
María Antonia Miguel Gómez
Site Name
Hospital Universitario Virgen De Valme
Department Name
infectious diseases
Contact Person Name
Nicolás Merchante Gutiérrez
Contact Person Email
nicolasmerchante@gmail.com
Site Name
Hospital Universitario De Cruces
Department Name
infectious diseases
Contact Person Name
Ane Josune Goikoetxea
Site Name
Hospital Universitario La Paz
Department Name
infectious diseases
Contact Person Name
María Belén Loeches Yagüe
Contact Person Email
bloeches@yahoo.es
Site Name
Hospital Universitario Donostia
Department Name
infectious diseases
Contact Person Name
Maialen Ibarguren Pinilla
Site Name
Bellvitge University Hospital
Department Name
infectious diseases
Contact Person Name
Mireia Puig Asensio
Contact Person Email
mireiapuigas@hotmail.com

Sponsor

Primary sponsor

Full Name
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Quofenix 450 mg tablets
Active Substance
DELAFLOXACIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
0.9 g
Investigational Product Name
Fetcroja 1 g powder for concentrate for solution for infusion
Active Substance
CEFIDEROCOL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
3 g
Investigational Product Name
Azactam 1g polvo para solución inyectable
Active Substance
AZTREONAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
8 g
Investigational Product Name
CIPROFLOXACINO KABI 2 mg/ml solución para perfusion
Active Substance
CIPROFLOXACIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
1.2 g
Investigational Product Name
Levofloxacino Kabi 5 mg/ml solución para perfusión.
Active Substance
LEVOFLOXACIN HEMIHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
1 g
Investigational Product Name
Amicacina Braun 500 mg Solución inyectable
Active Substance
AMIKACIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
3.6 g
Investigational Product Name
Tobramicina NORMON 50 mg/2 ml solución inyectable EFG
Active Substance
TOBRAMYCIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
0.84 g
Investigational Product Name
Colistimetato de sodio Altan Pharma 2 millones de UI polvo para solución inyectable y para perfusión
Active Substance
COLISTIMETHATE SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
9 million IU
Investigational Product Name
Imipenem/Cilastatina Kabi 500/500 mg, polvo para solución para perfusión
Active Substance
CILASTATIN SODIUM, IMIPENEM MONOHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
4 g
Investigational Product Name
Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion
Active Substance
TAZOBACTAM, CEFTOLOZANE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
9 g
Investigational Product Name
Meropenem Qilu 1 g polvo para solución inyectable y para perfusión EFG
Active Substance
MEROPENEM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
6 g
Investigational Product Name
Cefepima Accord 1 g polvo para solución inyectable y para perfusión EFG
Active Substance
CEFEPIME
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
6 g
Investigational Product Name
Quofenix 300 mg powder for concentrate for solution for infusion
Active Substance
DELAFLOXACIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
0.6 g
Investigational Product Name
ciprofloxacino cinfa 750 mg comprimidos recubiertos EFG
Active Substance
CIPROFLOXACIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
1.5 g
Investigational Product Name
Vaborem 1 g/1 g powder for concentrate for solution for infusion
Active Substance
MEROPENEM, VABORBACTAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
12 g
Investigational Product Name
MONOFLOX 500 mg comprimidos recubiertos con película EFG
Active Substance
LEVOFLOXACIN HEMIHYDRATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
1 g
Investigational Product Name
Ceftazidima SALA 1.000 mg polvo para solución para perfusión EFG
Active Substance
CEFTAZIDIME
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
6 g
Investigational Product Name
Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion
Active Substance
CEFTAZIDIME, AVIBACTAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
7.5 g
Investigational Product Name
Piperacilina/Tazobactam Accord 4 g/0,5 g polvo para solución para perfusión EFG
Active Substance
PIPERACILLIN, TAZOBACTAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
13.5 g
Combination Treatment
Yes

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