DDrare: Database of Drug Development for Rare Diseases

Flucloxacillin 250mg/5ml sugar-free powder for oral solution (DrugBank: Flucloxacillin)

告示番号	疾患名（ページ内リンク）	臨床試験数
299	嚢胞性線維症	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	EUCTR2016-002578-11-GB (EUCTR)	16/09/2016	09/08/2016	A trial to determine the safest and most effective antibiotic strategy for infants diagnosed with CF.	The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent for infants with CF. - CF START	Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution Product Name: Flucloxacillin Product Code: na INN or Proposed INN: Flucloxacillin	Alder Hey Children's NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 4	United Kingdom

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

EUCTR2016-002578-11-GB
(EUCTR)

16/09/2016

09/08/2016

A trial to determine the safest and most effective antibiotic strategy for infants diagnosed with CF.

The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent for infants with CF. - CF START

Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trade Name: Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution
Product Name: Flucloxacillin
Product Code: na
INN or Proposed INN: Flucloxacillin

Alder Hey Children's NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 4

United Kingdom