DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
60	再生不良性貧血	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2014-001546-25-NL (EUCTR)	06/01/2015	19/11/2014	Short versus extended antibiotic treatment for fever during low white blood cell counts in hematology patients with fever of unknown origin.	Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial. - SHORT-trial	Febrile neutropenia MedDRA version: 19.1;Level: PT;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.1;Level: LLT;Classification code 10002969;Term: Aplastic anemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 19.1;Classification code 10003999;Term: Bacteremia;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.1;Classification code 10007810;Term: Catheter related infection;Classification code 10028566;Term: Myeloma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1;Classification code 10062957;Term: Catheter bacteraemia;Classification code 10025310;Term: Lymphoma;Classification code 10024329;Term: Leukemia;Classification code 10056520;Term: Catheter site infection;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: imipenem-cilastatine Product Name: imipenem / cilastatine Product Code: RVG 101614 INN or Proposed INN: IMIPENEM INN or Proposed INN: Cilastatin Other descriptive name: CILASTATIN Trade Name: Meropenem Product Name: meropenem Product Code: RVG 105155 INN or Proposed INN: Meropenem Other descriptive name: MEROPENEM	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 4	Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-001546-25-NL
(EUCTR)

06/01/2015

19/11/2014

Short versus extended antibiotic treatment for fever during low white blood cell counts in hematology patients with fever of unknown origin.

Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial. - SHORT-trial

Febrile neutropenia
MedDRA version: 19.1;Level: PT;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 19.1;Level: LLT;Classification code 10002969;Term: Aplastic anemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 19.1;Classification code 10003999;Term: Bacteremia;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.1;Classification code 10007810;Term: Catheter related infection;Classification code 10028566;Term: Myeloma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.1;Classification code 10062957;Term: Catheter bacteraemia;Classification code 10025310;Term: Lymphoma;Classification code 10024329;Term: Leukemia;Classification code 10056520;Term: Catheter site infection;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Trade Name: imipenem-cilastatine
Product Name: imipenem / cilastatine
Product Code: RVG 101614
INN or Proposed INN: IMIPENEM
INN or Proposed INN: Cilastatin
Other descriptive name: CILASTATIN
Trade Name: Meropenem
Product Name: meropenem
Product Code: RVG 105155
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 4

Netherlands