None listed
Conditions
Brief summary
The aim of the study is to find out if oral antibiotics can be used instead of immunoglobulin (Ig) for preventing infections in patients with blood cancers, and if the oral antibiotics should be taken every day or only once symptoms of infection occur. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have received Ig treatment for over 6 months. Study details Participants will be randomised (allocated by chance) to one of three treatment groups, as follows: - stop Ig, and be given oral antiobiotics (such as co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg) to take every day - stop Ig, and be given oral antibiotics (amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg) to keep at home, and used only if infection symptoms occur - continue receiving their usual Ig treatment The duration of each treatment is for 12 months. Over the course of the 13 month study participation period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period. Types of assessments and data collected will include: medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data. It is hoped that this study will confirm if Ig used to prevent infections can be safely stopped, and if oral antibiotics should be given as an alternative, thus improving treatment for people with blood cancer.
Interventions
Arm A: Stop Immunoglobulin (Ig) and commence prophylactic oral antibiotics. - Once daily trimethoprim-sulfamethoxazole (co-trimoxazole), oral tablet, 160mg/800mg. Nb: Doxycycline 100mg daily as an alternative for participants with hypersensitivity to co-trimoxazole. - Dose adjustments: If a participant has cytopenia or renal impairment a 50% dose reduction may be made depending on the cause and/or severity of the cytopenia or renal impairment. Participants may be switched to the alternative antibiotic or Ig, or discontinued from their assigned trial treatment. Arm B: Stop Ig. - Participants will be prescribed amoxycillin/clavulanic acid, oral tablet, 1750-2000mg/250mg once only, and ciprofloxacin, oral tablet, 750 mg once only, to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical. Nb: clindamycin 600 mg is permitted as an alternative to amoxycillin/clavulanic acid for participants with hypersensitivity to penicillin. Duration of Arm A and Arm B Intervention: 12 months. If a participant on Arm A or Arm B experiences a Grade 3 or higher infectious complication, they may recommence Ig replacement, as directed by their treating clinician. The treating clinician may discontinue participants from their assigned treatment if continued participation is no longer in the participant's best interest. If a participant is discontinued from their assigned treatment, participation in the trial will not end. Trial follow-up and data collection will continue. Participants will be asked to complete a daily study diary to monitor oral antibiotic use and adherence to the interventions.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged greater than or equal to 18 years of age 2. Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL). 3. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months. 4. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator. 5. Life expectancy greater than 12 months. 6. Able to give informed consent, and willing and able to comply with each of the treatment arms.
Exclusion criteria
1. Prior or planned allogeneic haematopoietic stem cell transplantation. 2. Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring antimicrobial treatment. 3. Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and PJP prophylaxis). 4. Intolerance of all trial antibiotic options in either arm A or arm B. 5. Communication, compliance or logistical issues that are likely to limit patient’s ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection. 6. Pregnant or breastfeeding. 7. Severe renal impairment (estimated or measured creatinine clearance of less than 30 mL/min). 8. Previous splenectomy. 9. Previous participation in this trial. 10. Treating team deems enrolment in the study is not in the best interests of the patient.
Outcome results
None listed