Hematological MalignancyMESI-HMNCT07900542
Middle East Study of Infections in Patients With Hematological Malignancies
An observational study of Hematological Malignancy and Hematopoetic Stem Cell Transplantation, run by Hamad Medical Corporation at 9 sites in 5 countries.
Trial summary
The goal of this prospective observational study is to is to prospectively study the epidemiology of bloodstream infection (BSI) in patients with hematological malignancies (HM) and hematopoietic stem cell transplant (HSCT) recipients across the Middle East. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy, Hematopoetic Stem Cell Transplantation, Bloodstream Infection
- How many people
- 1,000 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 15 Sep 2024to 31 Dec 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults, aged 18 years or more, with active hematological malignancy or past receipt of hematopoietic stem cell transplant.
Who may be able to join
- Active underlying hematological malignancy or hematopoietic stem cell transplant recipient.
- Bloodstream infection ( a blood culture yielding a growth of ≥1 micro-organism that is considered to be clinically significant and is actively treated by the attending physicians).
Who cannot join
- A bloodstream infection within 14 days of an already enrolled bloodstream infection, or at any time before resolution of active signs of infections associated with an already enrolled episode.
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
Saudi Arabia4 sites, 4 recruiting
- Recruiting
King Fahad Specialist Hospital
Dammam
Yamama Jishi, MD, 00966138043333, yamama.jishi@gmail.com
- Recruiting
King Abdullah International Medical Research Center
Jeddah
Hadeel Altayib, MD, 00966122266666 ext. 66611, altayibha@mngha.med.sa
- Recruiting
King Faisal Specialist Hospital and Research Center, Jeddah
Jeddah
Rabia Aldoghaither, MD, 00966126677777 ext. 61201, raldoghaither@kfshrc.edu.sa
- Recruiting
King Faisal Specialist Hospital and Research Center, Riyadh
Riyadh
Riad Fakeeh, MD, 00966114647272 ext. 20407, relfakih1@kfshrc.edu.sa
United Arab Emirates2 sites, 2 recruiting
- Recruiting
Sheikh Shakbout Medical City
Abu Dhabi
Robert Swaka, MBBS, MSc, 0097123142893, rswaka@ssmc.ae
- Recruiting
Rashid Hospital
Dubai
Hanan Albasata, MD, 0097142191000, hamalbasata@dubaihealth.ae
Jordan1 site, 1 recruiting
- Recruiting
King Hussein Cancer Center
Amman
Haneen Younes, MD, 00962798777222, YH.09758@KHCC.JO
Oman1 site, 1 recruiting
- Recruiting
Royal Hospital
Muscat
Faryal Khamis, MD, 0096890669066, Khami001@gmail.com
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha
Ali Omrani, FRCP, FRCPath, 0097444396285, aomrani@hamad.qa
Aseel H. Alzibdeh, MD, 0097444396285, aalzibdeh@hamad.qa
About this study
The goal of this prospective observational study is to is to prospectively study the epidemiology of bloodstream infection (BSI) in patients with hematological malignancies (HM) and hematopoietic stem cell transplant (HSCT) recipients across the Middle East.
The objectives are to describe the epidemiological trends, identify risk factors for inappropriate antimicrobial therapy, and predictors of persistent BSI, microbiological relapse, and all-cause mortality.
The study is entirely observational, participants will receive standard clinical care as directed by their treating doctors.
Read the detailed description
The study includes centers in Qatar, Saudi Arabia, Oman, the United Arab Emirates and Jordan. Patients age 18 years or more, who have an underlying hematological malignancy (HM) or past hematopoietic stem cell transplantation (HSCT), and experience a bloodstream infection (BSI) will be prospectively enrolled. Each participating center will enroll up to 100 BSI episodes.
Data collection will include demographics, clinical characteristics of the underlying HM and/or HSCT, Charlson Co-morbidity Score, Pitt bacteremia score, vital signs, baseline laboratory findings, suspected source of infection, the presence of any vascular lines or other prosthesis, invasive procedures, immune modulating/suppressive therapy; date, species, antimicrobial susceptibility, resistance genes of blood culture isolates, antimicrobial management (empiric and targeted), and need for critical care support (including vasopressor support, renal replacement, and/or mechanical ventilation). Follow up will include clinical and laboratory parameters and microbiological investigations up to 30 days after the date of the index blood culture.
Coded, de-identified data will be uploaded through a secure electronic data capture tool (Caster EDC). Access is controlled by the Principal Investigator.
Outcomes include:
- Overall BSI incidence per 1,000 patient days.
- BSI incidence per 1,000 patient days by type of microorganism.
- Risk factors for inappropriate empiric therapy.
- Rate and risk factors for persistent BSI (defined as the isolation of the same clinically significant microorganism(s) from blood cultures collected ≥7 days after the index blood culture).
- Rate and risk factor for microbiological relapse within 90 days (defined as the recovery of the same species as that isolated from the index blood culture from a blood culture drawn anytime between discontinuation of active therapy for the index culture and the end of follow up).
- Rate and risk factors for all-cause mortality at 7 days, 14 days, and 30 days.
Descriptive results for quantitative variables will be presented as the mean and standard deviation or median with interquartile range, depending of data distribution. Numbers (percentage) will be reported for qualitative variables. Bivariate analysis will be performed using Independent Sample t-test or Mann Whitney U-test for quantitative variables, and Chi-Square test or Fisher Exact test for qualitative variables.
BSI incidence per 1,000 patient days will be reported, with 95% confidence intervals. Logistic regression models will be used to identify associations with inappropriate empiric therapy, and persistent BSI. Kaplan-Meier survival curves with log-rank P values will be used to assess time to microbiological relapse and all-cause mortality. In addition, Cox proportional hazards will be used to identify independent predictors of microbiological relapse and all-cause mortality.
All statistical analyses will be performed on Stata Statistical Software (StataCorp., College Station, Texas).
This will be an entirely observational study without any direct or indirect intervention, with appropriate confidentiality protection measures. IRB has granted a waiver of informed consent for this project.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- bloodstream infection, bacteremia, candidemia, fungemia, HSCT, hematological malignancy, hematology
- Medical subject headings
- Hematologic Neoplasms, Sepsis, Bacteremia, Candidemia, Fungemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
The study does not involve any investigational interventions. Participants will receive standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Bloodstream infection | Bloodstream infection Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall bloodstream infection incidence per 1,000 patient days
Overall bloodstream infection incidence per 1,000 patient days
Measured: 30 days
Secondary outcomes (3)
Persistent bloodstream infection
The isolation of the same clinically significant microorganism(s) from blood cultures collected ≥7 days after the index blood culture.
Measured: 30 days
Microbiological relapse
The recovery of the same species as that isolated from the index blood culture from a blood culture drawn anytime between discontinuation of active therapy for the index culture and the end of follow up.
Measured: 90 days
All-cause mortality
All-cause mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start15 Sep 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King Faisal Specialist Hospital & Research Center, King Fahad Specialist Hospital Dammam, King Abdullah International Medical Research Center, Sheikh Shakhbout Medical City, Royal Hospital, Oman, Rashid Hospital, King Hussein Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900542
- Sponsor's protocol ID
- MRC-01-23-912
- Other IDs
- MRC-01-23-912
- Acronym
- MESI-HM
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will depend on organizational policies and permissions.
Publications
Hadi HA, Al-Hail H, Aboidris LE, Al-Orphaly M, Ahmed MAS, Samuel BG, Mohamed HA, Sultan AA, Skariah S. Prevalence and genetic characterization of clinically relevant extended-spectrum beta-lactamase-producing Enterobacterales in the Gulf Cooperation Council countries. Front Antibiot. 2023 Jun 26;2:1177954. doi: 10.3389/frabi.2023.1177954. eCollection 2023.
PubMed 39816644El Omri H, Padmanabhan R, Taha RY, Kassem N, Elsabah H, Ellahie AY, Santimano AJJ, Al-Maslamani MA, Omrani AS, Elomri A, El Omri A. Dissecting bloodstream infections in febrile neutropenic patients with hematological malignancies, a decade-long single center retrospective observational study (2009-2019). J Infect Public Health. 2024 Jan;17(1):152-162. doi: 10.1016/j.jiph.2023.11.017. Epub 2023 Nov 21.
PubMed 38029491Cattaneo C, Di Blasi R, Skert C, Candoni A, Martino B, Di Renzo N, Delia M, Ballanti S, Marchesi F, Mancini V, Orciuolo E, Cesaro S, Prezioso L, Fanci R, Nadali G, Chierichini A, Facchini L, Picardi M, Malagola M, Orlando V, Trecarichi EM, Tumbarello M, Aversa F, Rossi G, Pagano L; SEIFEM Group. Bloodstream infections in haematological cancer patients colonized by multidrug-resistant bacteria. Ann Hematol. 2018 Sep;97(9):1717-1726. doi: 10.1007/s00277-018-3341-6. Epub 2018 Apr 28.
PubMed 29705860Martinez-Nadal G, Puerta-Alcalde P, Gudiol C, Cardozo C, Albasanz-Puig A, Marco F, Laporte-Amargos J, Moreno-Garcia E, Domingo-Domenech E, Chumbita M, Martinez JA, Soriano A, Carratala J, Garcia-Vidal C. Inappropriate Empirical Antibiotic Treatment in High-risk Neutropenic Patients With Bacteremia in the Era of Multidrug Resistance. Clin Infect Dis. 2020 Mar 3;70(6):1068-1074. doi: 10.1093/cid/ciz319.
PubMed 31321410Puerta-Alcalde P, Cardozo C, Marco F, Suarez-Lledo M, Moreno E, Morata L, Fernandez-Aviles F, Gutierrez-Garcia G, Chumbita M, Rosinol L, Martinez JA, Martinez C, Mensa J, Urbano A, Rovira M, Soriano A, Garcia-Vidal C. Changing epidemiology of bloodstream infection in a 25-years hematopoietic stem cell transplant program: current challenges and pitfalls on empiric antibiotic treatment impacting outcomes. Bone Marrow Transplant. 2020 Mar;55(3):603-612. doi: 10.1038/s41409-019-0701-3. Epub 2019 Sep 30.
PubMed 31570779Gudiol C, Aguilar-Guisado M, Azanza JR, Candel FJ, Canton R, Carratala J, Garcia-Vidal C, Jarque I, Lizasoain M, Gil-Bermejo JM, Ruiz-Camps I, Sanchez-Ortega I, Solano C, Suarez-Lledo M, Vazquez L, de la Camara R. Executive summary of the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Network for Research in Infectious Diseases (REIPI) and the Spanish Society of Haematology and Haemotherapy (SEHH) on the management of febrile neutropenia in patients with hematological malignancies. Enferm Infecc Microbiol Clin (Engl Ed). 2020 Apr;38(4):174-181. doi: 10.1016/j.eimc.2019.01.013. Epub 2019 Mar 27. English, Spanish.
PubMed 30926172Omrani AS, Almaghrabi RS. Complications of hematopoietic stem cell transplantation: Bacterial infections. Hematol Oncol Stem Cell Ther. 2017 Dec;10(4):228-232. doi: 10.1016/j.hemonc.2017.05.018. Epub 2017 Jul 3.
PubMed 28692817de la Court JR, Bruns AHW, Roukens AHE, Baas IO, van Steeg K, Toren-Wielema ML, Tersmette M, Blijlevens NMA, Huis In 't Veld RAG, Wolfs TFW, Tissing WJE, Kyuchukova Y, Heijmans J. The Dutch Working Party on Antibiotic Policy (SWAB) Recommendations for the Diagnosis and Management of Febrile Neutropenia in Patients with Cancer. Infect Dis Ther. 2022 Dec;11(6):2063-2098. doi: 10.1007/s40121-022-00700-1. Epub 2022 Oct 14.
PubMed 36229765Averbuch D, Orasch C, Cordonnier C, Livermore DM, Mikulska M, Viscoli C, Gyssens IC, Kern WV, Klyasova G, Marchetti O, Engelhard D, Akova M; ECIL4, a joint venture of EBMT, EORTC, ICHS, ESGICH/ESCMID and ELN. European guidelines for empirical antibacterial therapy for febrile neutropenic patients in the era of growing resistance: summary of the 2011 4th European Conference on Infections in Leukemia. Haematologica. 2013 Dec;98(12):1826-35. doi: 10.3324/haematol.2013.091025.
PubMed 24323983Chumbita M, Puerta-Alcalde P, Yanez L, Angeles Cuesta M, Chinea A, Espanol-Morales I, Fernandez-Abellan P, Gudiol C, Gonzalez-Sierra P, Rojas R, Sanchez-Pina JM, Vadillo IS, Sanchez M, Varela R, Vazquez L, Guerreiro M, Monzo P, Lopera C, Aiello TF, Peyrony O, Soriano A, Garcia-Vidal C. High Rate of Inappropriate Antibiotics in Patients with Hematologic Malignancies and Pseudomonas aeruginosa Bacteremia following International Guideline Recommendations. Microbiol Spectr. 2023 Aug 17;11(4):e0067423. doi: 10.1128/spectrum.00674-23. Epub 2023 Jun 27.
PubMed 37367629Abid FB, Tsui CKM, Doi Y, Deshmukh A, McElheny CL, Bachman WC, Fowler EL, Albishawi A, Mushtaq K, Ibrahim EB, Doiphode SH, Hamed MM, Almaslmani MA, Alkhal A, Butt AA, Omrani AS. Molecular characterization of clinical carbapenem-resistant Enterobacterales from Qatar. Eur J Clin Microbiol Infect Dis. 2021 Aug;40(8):1779-1785. doi: 10.1007/s10096-021-04185-7. Epub 2021 Feb 22.
PubMed 33616788Cassini A, Hogberg LD, Plachouras D, Quattrocchi A, Hoxha A, Simonsen GS, Colomb-Cotinat M, Kretzschmar ME, Devleesschauwer B, Cecchini M, Ouakrim DA, Oliveira TC, Struelens MJ, Suetens C, Monnet DL; Burden of AMR Collaborative Group. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473-3099(18)30605-4. Epub 2018 Nov 5.
PubMed 30409683
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle East Study of Infections in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07900542
- Acronym / sponsor ID
- MESI-HM / MRC-01-23-912
- Keywords
- bloodstream infection, bacteremia, candidemia, fungemia, HSCT, hematological malignancy, hematology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- King Faisal Specialist Hospital & Research Center, King Fahad Specialist Hospital Dammam, King Abdullah International Medical Research Center, Sheikh Shakhbout Medical City, Royal Hospital, Oman, Rashid Hospital, King Hussein Cancer Center
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective observational study is to is to prospectively study the epidemiology of bloodstream infection (BSI) in patients with hematological malignancies (HM) and hematopoietic stem cell transplant (HSCT) recipients across the Middle East.
The objectives are to describe the epidemiological trends, identify risk factors for inappropriate antimicrobial therapy, and predictors of persistent BSI, microbiological relapse, and all-cause mortality.
The study is entirely observational, participants will receive standard clinical care as directed by their treating doctors.
Detailed description
The study includes centers in Qatar, Saudi Arabia, Oman, the United Arab Emirates and Jordan. Patients age 18 years or more, who have an underlying hematological malignancy (HM) or past hematopoietic stem cell transplantation (HSCT), and experience a bloodstream infection (BSI) will be prospectively enrolled. Each participating center will enroll up to 100 BSI episodes.
Data collection will include demographics, clinical characteristics of the underlying HM and/or HSCT, Charlson Co-morbidity Score, Pitt bacteremia score, vital signs, baseline laboratory findings, suspected source of infection, the presence of any vascular lines or other prosthesis, invasive procedures, immune modulating/suppressive therapy; date, species, antimicrobial susceptibility, resistance genes of blood culture isolates, antimicrobial management (empiric and targeted), and need for critical care support (including vasopressor support, renal replacement, and/or mechanical ventilation). Follow up will include clinical and laboratory parameters and microbiological investigations up to 30 days after the date of the index blood culture.
Coded, de-identified data will be uploaded through a secure electronic data capture tool (Caster EDC). Access is controlled by the Principal Investigator.
Outcomes include:
- Overall BSI incidence per 1,000 patient days.
- BSI incidence per 1,000 patient days by type of microorganism.
- Risk factors for inappropriate empiric therapy.
- Rate and risk factors for persistent BSI (defined as the isolation of the same clinically significant microorganism(s) from blood cultures collected ≥7 days after the index blood culture).
- Rate and risk factor for microbiological relapse within 90 days (defined as the recovery of the same species as that isolated from the index blood culture from a blood culture drawn anytime between discontinuation of active therapy for the index culture and the end of follow up).
- Rate and risk factors for all-cause mortality at 7 days, 14 days, and 30 days.
Descriptive results for quantitative variables will be presented as the mean and standard deviation or median with interquartile range, depending of data distribution. Numbers (percentage) will be reported for qualitative variables. Bivariate analysis will be performed using Independent Sample t-test or Mann Whitney U-test for quantitative variables, and Chi-Square test or Fisher Exact test for qualitative variables.
BSI incidence per 1,000 patient days will be reported, with 95% confidence intervals. Logistic regression models will be used to identify associations with inappropriate empiric therapy, and persistent BSI. Kaplan-Meier survival curves with log-rank P values will be used to assess time to microbiological relapse and all-cause mortality. In addition, Cox proportional hazards will be used to identify independent predictors of microbiological relapse and all-cause mortality.
All statistical analyses will be performed on Stata Statistical Software (StataCorp., College Station, Texas).
This will be an entirely observational study without any direct or indirect intervention, with appropriate confidentiality protection measures. IRB has granted a waiver of informed consent for this project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bloodstream infection | – | Other: No Intervention: Observational CohortBloodstream infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, aged 18 years or more, with active hematological malignancy or past receipt of hematopoietic stem cell transplant.
Key inclusion criteria (2 listed)
- Active underlying hematological malignancy or hematopoietic stem cell transplant recipient.
- Bloodstream infection ( a blood culture yielding a growth of ≥1 micro-organism that is considered to be clinically significant and is actively treated by the attending physicians).
Key exclusion criteria (1 listed)
- A bloodstream infection within 14 days of an already enrolled bloodstream infection, or at any time before resolution of active signs of infections associated with an already enrolled episode.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThe study does not involve any investigational interventions. Participants will receive standard clinical care. | Other | Bloodstream infection |
Primary outcome
Overall bloodstream infection incidence per 1,000 patient days
Time frame: 30 days
Overall bloodstream infection incidence per 1,000 patient days
3 secondary outcomes
Persistent bloodstream infection
Time frame: 30 days
Microbiological relapse
Time frame: 90 days
All-cause mortality
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 39816644Hadi HA, Al-Hail H, Aboidris LE, Al-Orphaly M, Ahmed MAS, Samuel BG, Mohamed HA, Sultan AA, Skariah S. Prevalence and genetic characterization of clinically relevant extended-spectrum beta-lactamase-producing Enterobacterales in the Gulf Cooperation Council countries. Front Antibiot. 2023 Jun 26;2:1177954. doi: 10.3389/frabi.2023.1177954. eCollection 2023.
- Background: PubMed 38029491El Omri H, Padmanabhan R, Taha RY, Kassem N, Elsabah H, Ellahie AY, Santimano AJJ, Al-Maslamani MA, Omrani AS, Elomri A, El Omri A. Dissecting bloodstream infections in febrile neutropenic patients with hematological malignancies, a decade-long single center retrospective observational study (2009-2019). J Infect Public Health. 2024 Jan;17(1):152-162. doi: 10.1016/j.jiph.2023.11.017. Epub 2023 Nov 21.
- Background: PubMed 29705860Cattaneo C, Di Blasi R, Skert C, Candoni A, Martino B, Di Renzo N, Delia M, Ballanti S, Marchesi F, Mancini V, Orciuolo E, Cesaro S, Prezioso L, Fanci R, Nadali G, Chierichini A, Facchini L, Picardi M, Malagola M, Orlando V, Trecarichi EM, Tumbarello M, Aversa F, Rossi G, Pagano L; SEIFEM Group. Bloodstream infections in haematological cancer patients colonized by multidrug-resistant bacteria. Ann Hematol. 2018 Sep;97(9):1717-1726. doi: 10.1007/s00277-018-3341-6. Epub 2018 Apr 28.
- Background: PubMed 31321410Martinez-Nadal G, Puerta-Alcalde P, Gudiol C, Cardozo C, Albasanz-Puig A, Marco F, Laporte-Amargos J, Moreno-Garcia E, Domingo-Domenech E, Chumbita M, Martinez JA, Soriano A, Carratala J, Garcia-Vidal C. Inappropriate Empirical Antibiotic Treatment in High-risk Neutropenic Patients With Bacteremia in the Era of Multidrug Resistance. Clin Infect Dis. 2020 Mar 3;70(6):1068-1074. doi: 10.1093/cid/ciz319.
- Background: PubMed 31570779Puerta-Alcalde P, Cardozo C, Marco F, Suarez-Lledo M, Moreno E, Morata L, Fernandez-Aviles F, Gutierrez-Garcia G, Chumbita M, Rosinol L, Martinez JA, Martinez C, Mensa J, Urbano A, Rovira M, Soriano A, Garcia-Vidal C. Changing epidemiology of bloodstream infection in a 25-years hematopoietic stem cell transplant program: current challenges and pitfalls on empiric antibiotic treatment impacting outcomes. Bone Marrow Transplant. 2020 Mar;55(3):603-612. doi: 10.1038/s41409-019-0701-3. Epub 2019 Sep 30.
- Background: PubMed 30926172Gudiol C, Aguilar-Guisado M, Azanza JR, Candel FJ, Canton R, Carratala J, Garcia-Vidal C, Jarque I, Lizasoain M, Gil-Bermejo JM, Ruiz-Camps I, Sanchez-Ortega I, Solano C, Suarez-Lledo M, Vazquez L, de la Camara R. Executive summary of the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Network for Research in Infectious Diseases (REIPI) and the Spanish Society of Haematology and Haemotherapy (SEHH) on the management of febrile neutropenia in patients with hematological malignancies. Enferm Infecc Microbiol Clin (Engl Ed). 2020 Apr;38(4):174-181. doi: 10.1016/j.eimc.2019.01.013. Epub 2019 Mar 27. English, Spanish.
- Background: PubMed 28692817Omrani AS, Almaghrabi RS. Complications of hematopoietic stem cell transplantation: Bacterial infections. Hematol Oncol Stem Cell Ther. 2017 Dec;10(4):228-232. doi: 10.1016/j.hemonc.2017.05.018. Epub 2017 Jul 3.
- Background: PubMed 36229765de la Court JR, Bruns AHW, Roukens AHE, Baas IO, van Steeg K, Toren-Wielema ML, Tersmette M, Blijlevens NMA, Huis In 't Veld RAG, Wolfs TFW, Tissing WJE, Kyuchukova Y, Heijmans J. The Dutch Working Party on Antibiotic Policy (SWAB) Recommendations for the Diagnosis and Management of Febrile Neutropenia in Patients with Cancer. Infect Dis Ther. 2022 Dec;11(6):2063-2098. doi: 10.1007/s40121-022-00700-1. Epub 2022 Oct 14.
- Background: PubMed 24323983Averbuch D, Orasch C, Cordonnier C, Livermore DM, Mikulska M, Viscoli C, Gyssens IC, Kern WV, Klyasova G, Marchetti O, Engelhard D, Akova M; ECIL4, a joint venture of EBMT, EORTC, ICHS, ESGICH/ESCMID and ELN. European guidelines for empirical antibacterial therapy for febrile neutropenic patients in the era of growing resistance: summary of the 2011 4th European Conference on Infections in Leukemia. Haematologica. 2013 Dec;98(12):1826-35. doi: 10.3324/haematol.2013.091025.
- Background: PubMed 37367629Chumbita M, Puerta-Alcalde P, Yanez L, Angeles Cuesta M, Chinea A, Espanol-Morales I, Fernandez-Abellan P, Gudiol C, Gonzalez-Sierra P, Rojas R, Sanchez-Pina JM, Vadillo IS, Sanchez M, Varela R, Vazquez L, Guerreiro M, Monzo P, Lopera C, Aiello TF, Peyrony O, Soriano A, Garcia-Vidal C. High Rate of Inappropriate Antibiotics in Patients with Hematologic Malignancies and Pseudomonas aeruginosa Bacteremia following International Guideline Recommendations. Microbiol Spectr. 2023 Aug 17;11(4):e0067423. doi: 10.1128/spectrum.00674-23. Epub 2023 Jun 27.
- Background: PubMed 33616788Abid FB, Tsui CKM, Doi Y, Deshmukh A, McElheny CL, Bachman WC, Fowler EL, Albishawi A, Mushtaq K, Ibrahim EB, Doiphode SH, Hamed MM, Almaslmani MA, Alkhal A, Butt AA, Omrani AS. Molecular characterization of clinical carbapenem-resistant Enterobacterales from Qatar. Eur J Clin Microbiol Infect Dis. 2021 Aug;40(8):1779-1785. doi: 10.1007/s10096-021-04185-7. Epub 2021 Feb 22.
- Background: PubMed 30409683Cassini A, Hogberg LD, Plachouras D, Quattrocchi A, Hoxha A, Simonsen GS, Colomb-Cotinat M, Kretzschmar ME, Devleesschauwer B, Cecchini M, Ouakrim DA, Oliveira TC, Struelens MJ, Suetens C, Monnet DL; Burden of AMR Collaborative Group. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473-3099(18)30605-4. Epub 2018 Nov 5.
- Individual participant dataSharing planned: Undecided. Will depend on organizational policies and permissions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancy and Hematopoetic Stem Cell Transplantation, run by Hamad Medical Corporation at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Saudi Arabia, United Arab Emirates, Jordan, Oman, Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall bloodstream infection incidence per 1,000 patient days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07900542, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.