Trial · NCT00002850
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
NCT00002850, Phase 3, Completed, Gary Morrow; results first posted 2015-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy. Trials, record NCT00002850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00002850
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
- NCT number
- NCT00002850
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 212 participants, actual
- Lead sponsor
- Gary Morrow
- Conditions
- Infection, Multiple Myeloma
- Interventions
- ciprofloxacin, ofloxacin, 160 mg trimethoprim and 800 mg sulfamethoxazole
- First posted
- 2003-01-27
- Last updated
- 2015-11-11
- Results first posted
- 2015-02-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Experiencing a Serious Bacterial Infection | First three months of chemotherapy | This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Experiencing a Serious Bacterial Infection | First three months of chemotherapy | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Experiencing a Serious Bacterial Infection | Ciprofloxacin or Ofloxacin | 12.5 | 95% Confidence Interval 5.6 to 23.2 | percentage of participants | |
| Proportion of Patients Experiencing a Serious Bacterial Infection | TMP-SMX | 6.8 | 95% Confidence Interval 2.2 to 15.1 | percentage of participants | |
| Proportion of Patients Experiencing a Serious Bacterial Infection | No Prophylaxis | 15.9 | 95% Confidence Interval 7.9 to 27.3 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ciprofloxacin or Ofloxacin | 69 | |
| Overall Study | STARTED | TMP-SMX | 76 | |
| Overall Study | STARTED | Observation | 67 | |
| Overall Study | COMPLETED | Ciprofloxacin or Ofloxacin | 64 | |
| Overall Study | COMPLETED | TMP-SMX | 74 | |
| Overall Study | COMPLETED | Observation | 63 | |
| Overall Study | NOT COMPLETED | Ciprofloxacin or Ofloxacin | 5 | |
| Overall Study | NOT COMPLETED | TMP-SMX | 2 | |
| Overall Study | NOT COMPLETED | Observation | 4 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrush | Infections and infestations | Ciprofloxacin or Ofloxacin | 0 | 69 | |
| other | Thrush | Infections and infestations | TMP-SMX | 1 | 76 | |
| other | Thrush | Infections and infestations | Observation | 0 | 67 | |
| other | GI bleed | Gastrointestinal disorders | Ciprofloxacin or Ofloxacin | 1 | 69 | |
| other | GI bleed | Gastrointestinal disorders | TMP-SMX | 0 | 76 | |
| other | GI bleed | Gastrointestinal disorders | Observation | 0 | 67 | |
| serious | Death | General disorders | Ciprofloxacin or Ofloxacin | 1 | 69 | |
| serious | Death | General disorders | TMP-SMX | 0 | 76 | |
| serious | Death | General disorders | Observation | 0 | 67 | |
| serious | Renal failure | Renal and urinary disorders | Ciprofloxacin or Ofloxacin | 0 | 69 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ciprofloxacin or Ofloxacin | ||
| Total, all-cause mortality | TMP-SMX | ||
| Total, all-cause mortality | Observation | ||
| Total, other adverse events | Ciprofloxacin or Ofloxacin | 1 | 69 |
| Total, other adverse events | TMP-SMX | 1 | 76 |
| Total, other adverse events | Observation | 0 | 67 |
| Total, serious adverse events | Ciprofloxacin or Ofloxacin | 1 | 69 |
| Total, serious adverse events | TMP-SMX | 2 | 76 |
| Total, serious adverse events | Observation | 0 | 67 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA037420 | University of Rochester Cancer Center CCOP Research Base | MORROW, GARY R | UNIVERSITY OF ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2014 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00002850
GET https://conductscience.org/api/trials/v1/NCT00002850/registered