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	EUCTR2011-005152-34-ES (EUCTR)	26/03/2012	22/11/2011	Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia).	Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia	In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis. MedDRA version: 14.0;Level: PT;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0;Level: LLT;Classification code 10066156;Term: Empiric treatment;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	INN or Proposed INN: ACICLOVIR Other descriptive name: ACICLOVIR INN or Proposed INN: AMIKACIN Other descriptive name: AMIKACIN INN or Proposed INN: AMPHOTERICINE B, LIPOSOME Other descriptive name: AMPHOTERICINE B, LIPOSOME INN or Proposed INN: CASPOFUNGIN ACETATE Other descriptive name: CASPOFUNGIN ACETATE INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: CIPROFLOXACIN Other descriptive name: CIPROFLOXACIN INN or Proposed INN: TRIMETHOPRIM SULFATE Other descriptive name: TRIMETHOPRIM SULFATE INN or Proposed INN: SULFAMETH	José Miguel Cisneros Herreros	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Spain

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

EUCTR2011-005152-34-ES
(EUCTR)

26/03/2012

22/11/2011

Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia).

Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia

In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis.
MedDRA version: 14.0;Level: PT;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0;Level: LLT;Classification code 10066156;Term: Empiric treatment;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

INN or Proposed INN: ACICLOVIR
Other descriptive name: ACICLOVIR
INN or Proposed INN: AMIKACIN
Other descriptive name: AMIKACIN
INN or Proposed INN: AMPHOTERICINE B, LIPOSOME
Other descriptive name: AMPHOTERICINE B, LIPOSOME
INN or Proposed INN: CASPOFUNGIN ACETATE
Other descriptive name: CASPOFUNGIN ACETATE
INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: CIPROFLOXACIN
Other descriptive name: CIPROFLOXACIN
INN or Proposed INN: TRIMETHOPRIM SULFATE
Other descriptive name: TRIMETHOPRIM SULFATE
INN or Proposed INN: SULFAMETH

José Miguel Cisneros Herreros

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain