Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000980
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea
Sponsor:
Rhone-Poulenc Rorer
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea
Status:
COMPLETED
Status Verified Date:
1990-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea
Spiramycin a macrolide antibiotic has been studied in the United States for the treatment of cryptosporidial diarrhea Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients Results of one study however showed no significant difference between spiramycin and placebo inactive medication A later study indicated that the absorption of spiramycin is significantly decreased when food is present Thus the results of the trial may have been due to poor absorption of spiramycin
Spiramycin a macrolide antibiotic has been studied in the United States for the treatment of cryptosporidial diarrhea Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients Results of one study however showed no significant difference between spiramycin and placebo inactive medication A later study indicated that the absorption of spiramycin is significantly decreased when food is present Thus the results of the trial may have been due to poor absorption of spiramycin
Detailed Description:
Spiramycin a macrolide antibiotic has been studied in the United States for the treatment of cryptosporidial diarrhea Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients Results of one study however showed no significant difference between spiramycin and placebo inactive medication A later study indicated that the absorption of spiramycin is significantly decreased when food is present Thus the results of the trial may have been due to poor absorption of spiramycin
Patients are observed for 3 days to establish baseline conditions They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo they are not told which 6-day period they receive placebo All patients receive 15 days of spiramycin Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days Responders at either dose are followed weekly for 4 weeks Should a relapse occur patients receive an additional 15 days of therapy at the dose of spiramycin that initially produced a response following reestablishment of a baseline with 6 days of placebo Nonresponders to the higher dose are taken off the study
Patients are observed for 3 days to establish baseline conditions They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo they are not told which 6-day period they receive placebo All patients receive 15 days of spiramycin Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days Responders at either dose are followed weekly for 4 weeks Should a relapse occur patients receive an additional 15 days of therapy at the dose of spiramycin that initially produced a response following reestablishment of a baseline with 6 days of placebo Nonresponders to the higher dose are taken off the study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCB-301 | None | None | None |
| FDA 28A | None | None | None |