drugset / Trial / NCT07202052
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers. It is a comparison between Immunoglobulin and antibiotics use.
Timeline
- Start
- 2025-05-06
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin clavulanic acid | Unknown | 250 mg | — |
| Subject | Amoxicillin clavulanic acid | Unknown | 1750 mg | — |
| Subject | Amoxicillin clavulanic acid | Unknown | 2000 mg | — |
| Subject | Ciprofloxacin | Small molecule | 750 mg | — |
| Subject | Clindamycin | Unknown | 600 mg | — |
| Subject | Doxycycline | Small molecule | 100 mg | — |
| Subject | Intravenous immunoglobulin | Protein / enzyme biologic | 100 mg/kg | Intravenous |
| Subject | Intravenous immunoglobulin | Protein / enzyme biologic | 0.25 g/kg | Intravenous |
| Subject | Intravenous immunoglobulin | Protein / enzyme biologic | 0.4 g/kg | Intravenous |
| Subject | Trimethoprim / Sulfamethoxazole | Unknown | 160 mg | — |
| Subject | Trimethoprim / Sulfamethoxazole | Unknown | 800 mg | — |