Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

MERONEM: Observational Study About Efficacy of Meropenem in Comparison of Meropenem and Glycopeptide in Treatment of Neutropenia Febrile in Allogenic Blood Stem Cell Transplantation Patients

ClinicalTrials.gov ID

NCT00462878

Acronym / sponsor ID

MERONEM / 03-2002-GTA

Conditions

Allogenic Blood Stem Cell Transplantation, Febrile Neutropenia

Keywords

Febrile neutropenia

Study type

Observational

Recruitment status

Completed

Enrolment

392 participants (estimated)

Lead sponsor

PETHEMA FoundationUniversity, hospital or other

Study start

Nov 2002

Study completion

Apr 2009 (actual)

First posted

19 Apr 2007 (estimated)

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.

Study design

Observational model

Case only

Time perspective

Prospective

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Patients submitted to allogenic transplant with neutropenia (neutrophils account < 500/mm3 or neutrophils account < 1000/mm3 with prevision to decrease until 500/mm3 at the next 24-48 h); Signs and symptoms to infection; Fever (Temperature> 38,3 ºC registered one time, or 38 ºC en two times separated 60 minutes in a period of 12 h)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
• Background: PubMed 8957718Cometta A, Glauser MP. Empiric antibiotic monotherapy with carbapenems in febrile neutropenia: a review. J Chemother. 1996 Oct;8(5):375-81. doi: 10.1179/joc.1996.8.5.375.
• Background: PubMed 10605194Jarque I, Sanz MA. [Application of the concepts of evidence-based medicine to the evidence on the treatment of febrile neutropenia]. Enferm Infecc Microbiol Clin. 1999;17 Suppl 2:95-102. Spanish.
• Background: PubMed 9702394Klastersky J. Current attitudes for therapy of febrile neutropenia with consideration to cost-effectiveness. Curr Opin Oncol. 1998 Jul;10(4):284-90. doi: 10.1097/00001622-199807000-00002.
• Background: PubMed 11850858Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.
• Background: PubMed 9613785Koya R, Andersen J, Fernandez H, Goodman M, Spector N, Smith R, Hanlon J, Cassileth PA. Analysis of the value of empiric vancomycin administration in febrile neutropenia occurring after autologous peripheral blood stem cell transplants. Bone Marrow Transplant. 1998 May;21(9):923-6. doi: 10.1038/sj.bmt.1701201.
• Background: PubMed 10918433Celebi H, Akan H, Akcaglayan E, Ustun C, Arat M. Febrile neutropenia in allogeneic and autologous peripheral blood stem cell transplantation and conventional chemotherapy for malignancies. Bone Marrow Transplant. 2000 Jul;26(2):211-4. doi: 10.1038/sj.bmt.1702503.
• Background: PubMed 10021469Smith TL, Pearson ML, Wilcox KR, Cruz C, Lancaster MV, Robinson-Dunn B, Tenover FC, Zervos MJ, Band JD, White E, Jarvis WR. Emergence of vancomycin resistance in Staphylococcus aureus. Glycopeptide-Intermediate Staphylococcus aureus Working Group. N Engl J Med. 1999 Feb 18;340(7):493-501. doi: 10.1056/NEJM199902183400701.
• Background: PubMed 8869095Dompeling EC, Donnelly JP, Deresinski SC, Feld R, Lane-Allman EF, De Pauw BE. Early identification of neutropenic patients at risk of grampositive bacteraemia and the impact of empirical administration of vancomycin. Eur J Cancer. 1996 Jul;32A(8):1332-9. doi: 10.1016/0959-8049(96)00050-0.

Related trials for Allogenic Blood Stem Cell Transplantation

• RecruitingObservational study

  Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

  Leukemia, Lymphoma

• RecruitingPhase 1/2

  Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...

  HIV, Hematologic Malignancies

• Not yet recruitingEarly Phase 1

  A Clinical Study Evaluating the Safety and Preliminary Effectiveness of Induced Pluripotent Stem Cell-derived Platelets in Patients With Thrombocytopenia Caused by Allogeneic Hematopoietic Stem Cell Transplantation

  Thrombocytopenia

• Active, not recruitingEarly Phase 1

  Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide

  Chronic Granulomatous Disease

• Not yet recruiting

  Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT

  Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency

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. This study is not recruiting at the moment.

64 sites in 1 country: see every site and its status.