NCT07004049View on ClinicalTrials.gov

Optimising TREATment for Severe Gram-Negative Bacterial Infections

PHASE4RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

April 21, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Bloodstream InfectionVentilator Associated Bacterial PneumoniaHospital Acquired Bacterial PneumoniaCarbapenem Resistant Bacterial InfectionMultidrug Resistance
Interventions
DRUG

Colistin/Polymyxin B + Sulbactam

For carbapenem-resistant Acinetobacter infections in China, Malaysia, Thailand and Singapore

DRUG

Colistin/Polymyxin B + Tigecycline/Eravacycline

For carbapenem-resistant Acintobacter, carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand and Singapore

DRUG

Colistin/Polymyxin B + Meropenem

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in China, Malaysia and Singapore

DRUG

Ceftazidime-avibactam + Sulbactam

For carbapenem-resistant Acinetobacter infections in China, Malaysia, Thailand, Singapore and Australia.

DRUG

Ceftazidime-avibactam + Fosfomycin

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in Malaysia, Thailand and Singapore

DRUG

Ceftazidime-avibactam

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand, Singapore, Europe and Australia.

DRUG

Ceftazidime-avibactam + Aztreonam

For carbapenem-resistant Enterobacterales infections in China, Malaysia, Thailand, Singapore, Europe and Australia.

DRUG

Ceftazidime-avibactam + Colistin/Polymyxin B

For carbapenem-resistant Pseudomonas aeruginosa in China, Malaysia, Thailand, Singapore and Europe.

DRUG

High-dose meropenem

For carbapenem-resistant Enterobacterales infection in Europe

DRUG

Meropenem + Fosfomycin

For carbapenem-resistant Enterobacterales in Europe

DRUG

Meropenem-vaborbactam

For carbapenem-resistant Enterobacterales infection in Europe

DRUG

Cefiderocol

For carbapenem-resistant Pseudomonas aeruginosa, carbapenem-resistant Enterobacterales infections in Europe and Australia.

DRUG

Ceftolozane-tazobactam

For carbapenem-resistant Pseudomonas aeruginosa in Europe and Australia.

DRUG

Ceftolozane-tazobactam + Meropenem

For carbapenem-resistant Pseudomonas aeruginosa in Europe.

Trial Locations (41)

4006

NOT_YET_RECRUITING

Royal Brisbane and Women's Hospital, Brisbane

10400

NOT_YET_RECRUITING

Phramongkutkloa Hospital, Bangkok

NOT_YET_RECRUITING

Rajavithi Hospital, Bangkok

41009

NOT_YET_RECRUITING

Hospital Universitario Virgen Macarena, Seville

47000

NOT_YET_RECRUITING

Hospital Sungai Buloh, Sungai Buloh

50200

NOT_YET_RECRUITING

Maharaj Nakorn Chiang Mai Hospital, Chiangmai University, Chiang Mai

68000

NOT_YET_RECRUITING

Ampang Hospital, Ampang

88200

NOT_YET_RECRUITING

Queen Elizabeth I, Kota Kinabalu

88300

NOT_YET_RECRUITING

Queen Elizabeth II, Kota Kinabalu

98000

NOT_YET_RECRUITING

Miri Sarawak Hospital, Miri

119074

RECRUITING

National University Hospital, Singapore

221002

NOT_YET_RECRUITING

Xuzhou First People's Hospital, Xuzhou

310058

NOT_YET_RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

710006

NOT_YET_RECRUITING

The Second Affiliated Hospital, Xi'an Jiang Tong University, Xi'an

Unknown

NOT_YET_RECRUITING

Princess Alexandra Hospital, Brisbane

NOT_YET_RECRUITING

American University of Beirut Medical Center, Beirut

NOT_YET_RECRUITING

Hamad Medical Corporation, Doha

NOT_YET_RECRUITING

King Saud bin Abdulaziz University for Health Sciences, Riyadh

NOT_YET_RECRUITING

Helen Joseph Hospital, Johannesburg

NOT_YET_RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

NOT_YET_RECRUITING

Hospital Universitario de Badajoz, Badajoz

NOT_YET_RECRUITING

Hospital Universitario de Cruces, Barakaldo

NOT_YET_RECRUITING

Hospital Universitario Bellvitge, Barcelona

NOT_YET_RECRUITING

Hospital Universitario Reina Sofía Córdoba, Córdoba

NOT_YET_RECRUITING

Hospital Universitario San Cecilio, Granada

NOT_YET_RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

NOT_YET_RECRUITING

Hospital Clínico San Carlos, Madrid

NOT_YET_RECRUITING

Hospital General Universitario Gregorio Marañón, Madrid

NOT_YET_RECRUITING

Hospital Universitario de La Princesa, Madrid

NOT_YET_RECRUITING

Hospital Universitario La Paz, Madrid

NOT_YET_RECRUITING

Hospital Regional Universitario de Málaga, Málaga

NOT_YET_RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

NOT_YET_RECRUITING

Hospital Álvaro Cunqueiro, Pontevedra

NOT_YET_RECRUITING

Hospital Universitario de Donostia, San Sebastián

NOT_YET_RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

NOT_YET_RECRUITING

Hospital Universitario Virgen de Valme, Seville

NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocío, Seville

NOT_YET_RECRUITING

Hospital Clínico Universitario Lozano Blesa, Zaragoza

NOT_YET_RECRUITING

İstanbul Medipol Üniversitesi, Istanbul

NOT_YET_RECRUITING

Dubai Hospital, Dubai

08003

NOT_YET_RECRUITING

Hospital del Mar Barcelona, Barcelona

All Listed Sponsors
collaborator

The University of Queensland

OTHER

collaborator

European Clinical Research Alliance for Infectious Diseases (ECRAID)

OTHER

lead

National University of Singapore

OTHER