Clinical trial · Interventional
Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant
Randomized, Double Blinded, Placebo-Controlled Trial of Antibacterial Prophylaxis for the Prevention of Bacterial Infections in the Post-Engraftment Phase After Allogeneic Hematopoeitic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant. PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
| Infection | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| moxifloxacin hydrochloride | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- moxifloxacin hydrochloride
- description
- Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
- interventionNames
- Drug: moxifloxacin hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Sugar pill
- description
- Placebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- 1 to 120 days post bone marrow transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Must be planning to undergo or have completed allogeneic stem cell transplantation (ASCT) * Must not be undergoing a nonmyeloablative ASCT * Must not require antibiotic prophylaxis against bacterial pathogens during the post-engraftment phase as per ASCT protocol * No known colonization with an antimicrobial-resistant organism normally sensitive to quinolones that is known to increase infection incidence (i.e., ciprofloxacin-resistant Pseudomonas not allowed; vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus aureus allowed) PATIENT CHARACTERISTICS: * Life expectancy ≥ 100 days * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * No known hypersensitivity to fluoroquinolones * No prolonged QTc interval on EKG (i.e., QTc \> 440 milliseconds) * No uncontrolled hypokalemia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent class IA (e.g., quinidine or procainamide) or class III (e.g., amiodarone or sotalol) antiarrhythmics * No concurrent intravenous antibiotics for pre-enrollment infections except vancomycin, linezolid, dalfopristin, or quinupristin (Synercid®)
References
Publications (1)
- RESULTBubalo JS, Leis JF, Curtin PT, et al.: A randomized, double-blinded, pilot trial of aprepitant added to standard antiemetics during conditioning therapy for hematopoietic stem cell transplant (HSCT). [Abstract] J Clin Oncol 25 (Suppl 18): A-9112, 520s, 2007.