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NCT02981615
Phase 3 Multicenter Randomized Double Blind Placebo Controlled Study With Antibacterial Prophylaxis in Azacitidine Treated MDS Patients
Phase 3 trial testing Levofloxacin in Prevention in 67 participants. Completed in 30 July 2022.
30 July 2022
Quick facts
| Lead sponsor | Sheba Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 67 |
| Start date | 1 August 2017 |
| Primary completion | 30 July 2022 |
| Estimated completion | 30 July 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Levofloxacin (Levofloxacin) — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Prevention — all drugs for Prevention →
Sponsor
Sheba Medical Center
Who can join
18 and older, any sex, with Prevention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Infections are a major and prevalent life-threatening complication among patients with myelodysplastic syndrome (MDS). Currently, the role of prophylactic antibacterial agents after chemotherapy in MDS patients remains controversial and there are no clinical guidelines for infection prophylaxis in this clinical setting. We will conduct a prospective study to evaluate the potential benefit of prophylactic antibacterial (Levofloxacin) on the rate of febrile episodes/infections in Azacytidine treated MDS patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Historical expectations with DNA methyltransferase inhibitor monotherapy in MDS: when is combination therapy truly "promising"?
Brunner AM, Fell G, Steensma DP. · · 2022 · cited 3× · PMID 35143613 · DOI 10.1182/bloodadvances.2021006357
Verify or expand the search:
- PubMed search for NCT02981615
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Levofloxacin
Trials testing the same drug.
- NCT07528417 — Evaluation of Antibiotic Prophylaxis in Myelodysplastic Syndromes and Acute Myeloid Leukemia (MYELO-CAN:ABX) · Phase 2 · not yet recruiting
- NCT07320534 — Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase · Phase 4 · not yet recruiting
- NCT07198685 — 6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province · NA · not yet recruiting
- NCT07126639 — A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis · NA · not yet recruiting
- NCT05743101 — Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke · NA · not yet recruiting
Other recruiting trials for Prevention
Currently open trials in the same condition.
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Other Sheba Medical Center trials
Trials by the same sponsor.
- NCT07401524 — Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage · Phase 4 · not yet recruiting
- NCT07523373 — Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch · NA · not yet recruiting
- NCT07509229 — 9-cis Beta-Carotene-Rich Extract of Dunaliella Alga in Retinitis Pigmentosa Patients · Phase 1, PHASE2 · not yet recruiting
- NCT07405723 — Arm Position and Blood Pressure Measurement Accuracy During Pregnancy · NA · recruiting
- NCT07474987 — Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02981615 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sheba Medical Center
- Last refreshed: 27 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02981615.
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