Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Henry Ford Health

Status and phase: Completed; Phase 2

Conditions: Stem Cell Transplant Complications; Prophylaxis

Treatments: Drug: Ciprofloxacin; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT03850379

12124)

Details and patient eligibility

About

Ciprofloxacin and levofloxacin are both in guidelines to use for prophylaxis in autologous and allogeneic Stem cell transplant.Ciprofloxacin was recently replaced by levofloxacin as the preferred agent in some transplant centers. In some small retrospective studies ciprofloxacin prophylaxis was associated with a higher rate of breakthrough gram positive bloodstream infections. However, the optimum oral agent for antibacterial prophylaxis in transplant recipients remains uncertain.

Enrollment: 308 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18-75 years of age with a diagnosis of a hematological malignancy. Meet the stem cell transplant program criteria to undergo autologous or allogeneic hematopoietic stem cell transplantation.

Exclusion criteria

• Prolonged QT
• Allergies to ciprofloxacin or levofloxacin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Levo

Experimental group

Description:

Levofloxacin 500 mg once daily

Treatment:

Drug: Levofloxacin

Cipro

Active Comparator group

Description:

Ciprofloxacin 500 mg BID

Treatment:

Drug: Ciprofloxacin