MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tube... | NCT00495339

Studies
MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis

NCT00495339

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 4, 2009Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Tuberculosis, Pulmonary

Interventions

Levofloxacin

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Jul 2, 2007

First Submission Date that Met QC Criteria

Jul 2, 2007

First Posted Date

Jul 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2009

Last Update Posted Date

Mar 4, 2009Estimated

Description Module

Brief Summary

Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB.

Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Levofloxacin	Drug: Levofloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levofloxacin	Drug	500-1000 mg once a day daily per os with combination of drugs.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with bacterioexcretion		1 month, 2 months, 3 months
Dynamics of chest radiograph		3 months
Dynamics of Intoxication		1 month, 2 months, 3 months
All clinical and laboratory adverse events		from the signature of the Informed Concent Form (ICF) up to the end of the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Drug-resistant pulmonary tuberculosis laboratory diagnosed

Exclusion Criteria:

Known hypersensitivity to levofloxacin, other quinolones
Patient with epilepsy and central nervous system diseases
Renal insufficiency with serum creatinine lower than 50 ml/min
Arterial hypertension, ischemic heart disease in acute phase
Gastro-intestinal diseases, liver diseases in acute phase
History of drug and alcohol abuse
Patient with history of tendon disorders related to fluoroquinolone administration
Pregnancy and breast-feeding women
Immune system disorders related to chemotherapy, AIDS, long term administration of corticosteroids

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Marina Atarshchikova	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D014397	Tuberculosis, Pulmonary

Ancestor Terms

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064704	Levofloxacin

Ancestor Terms

ID	Term
D015242	Ofloxacin
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided