Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002850
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
1999-11-01
Brief Title:
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2015-10
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:
RATIONALE Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy
PURPOSE This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma
PURPOSE This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma
Detailed Description:
OBJECTIVES
Evaluate whether oral antibiotic prophylaxis with co-trimoxazole TMP-SMX versus ciprofloxacin CPFX or ofloxacin versus no prophylaxis will significantly reduce rates of serious bacterial infections during the first 3 months of chemotherapy in patients with multiple myeloma
Determine whether antibiotic prophylaxis with TMP-SMX or CPFX or ofloxacin is associated with an increased incidence of nonbacterial infection or an increased rate of infection from organisms resistant to prophylactic antibiotics
Evaluate whether oral antibiotic prophylaxis with CPFX or ofloxacin is as effective as TMP-SMX without the associated toxic effects
Evaluate whether protection against early infection in multiple myeloma patients can improve their response to initial chemotherapy
OUTLINE This is a randomized multicenter study Patients are stratified by participating center Patients are randomized to 1 of 2treatment arms
Arm I Patients receive co-trimoxazole every 12 hours for 2 months followed by observation for 2 months
Arm II Patients receive oral ciprofloxacin or ofloxacin every 12 hours for 2 months followed by observation for 1 month
Arm III The patient will receive no prophylaxis
Patients continue their randomly assigned treatment throughout any infection in addition to any treatment needed for infection Patients also remain on their randomly assigned treatment if chemotherapy is discontinued changed or delayed during the 3 month study
Patients are followed at 6 months 1 year and 2 years
PROJECTED ACCRUAL A total of 212 patients 71 per treatment arm will be accrued for this study
Evaluate whether oral antibiotic prophylaxis with co-trimoxazole TMP-SMX versus ciprofloxacin CPFX or ofloxacin versus no prophylaxis will significantly reduce rates of serious bacterial infections during the first 3 months of chemotherapy in patients with multiple myeloma
Determine whether antibiotic prophylaxis with TMP-SMX or CPFX or ofloxacin is associated with an increased incidence of nonbacterial infection or an increased rate of infection from organisms resistant to prophylactic antibiotics
Evaluate whether oral antibiotic prophylaxis with CPFX or ofloxacin is as effective as TMP-SMX without the associated toxic effects
Evaluate whether protection against early infection in multiple myeloma patients can improve their response to initial chemotherapy
OUTLINE This is a randomized multicenter study Patients are stratified by participating center Patients are randomized to 1 of 2treatment arms
Arm I Patients receive co-trimoxazole every 12 hours for 2 months followed by observation for 2 months
Arm II Patients receive oral ciprofloxacin or ofloxacin every 12 hours for 2 months followed by observation for 1 month
Arm III The patient will receive no prophylaxis
Patients continue their randomly assigned treatment throughout any infection in addition to any treatment needed for infection Patients also remain on their randomly assigned treatment if chemotherapy is discontinued changed or delayed during the 3 month study
Patients are followed at 6 months 1 year and 2 years
PROJECTED ACCRUAL A total of 212 patients 71 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-U1099 | OTHER | ECOG | httpsreporternihgovquickSearchU10CA037420 |
| U10CA037420 | NIH | None | None |
| URCC-U10994 | OTHER | None | None |
| NCI-C95-0001 | OTHER | None | None |
| URCC-URRSRB-6993 | OTHER | None | None |
| NCI-P96-0073 | OTHER | None | None |