Additional identifiers
EudraCT/CTIS number
2011-000366-35
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
10626; HTA 08/116/69
Study information
Scientific title
Tackling early morbidity and mortality in myeloma: assessing the benefit of antibiotic prophylaxis and its effect on healthcare associated infections
Acronym
TEAMM
Study hypothesis
TEAMM is a randomized, double-blind, placebo-controlled multi-centre phase III clinical trial assessing the benefit of antibiotic prophylaxis and its effect on health care associated infections.
The trial hypotheses are that levofloxacin used once daily as anti-bacterial prophylaxis in newly diagnosed symptomatic myeloma will:
1. Reduce the rate of febrile episodes, hospitalisation, and death
2. Increase response to anti-myeloma therapy
3. Improve quality of life and overall survival
The trial will also test if levofloxacin affects the carriage of and invasive infection by three important groups of bacteria; C. difficile, S. aureus (including methicillin-resistant Staphylococcus aureus [MRSA]) and Extended-Spectrum Beta-Lactamases (ESBL) coliforms.
1. Is the carriage of these organisms increased in patients receiving levofloxacin compared to those receiving placebo?
2. Is the carriage of these organisms associated with later invasive infections?
3. Does levofloxacin increase the rate of invasive infections by these three groups of organisms?
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0811669
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0020/52076/PRO-08-116-69.pdf
Ethics approval(s)
First MREC, 27/07/2011, ref: 11/WM/0220
Study design
Randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Haematological Oncology; Disease: Myeloma
Intervention
Antibiotic prophylaxis: 500mg of Levofloxacin or Placebo to match will be taken daily for 12 weeks during anti-myeloma chemotherapy
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Levofloxacin
Primary outcome measure
Number of febrile episodes from randomisation up to 12 weeks
Secondary outcome measures
1. Carriage and invasive infections with S. aureus, C. difficile and ESBL coliforms between 12 and 16 weeks to assess for delayed affects from the intervention that is stopped at 12 weeks
2. Carriage and invasive infections with S. aureus, C. difficile and ESBL coliforms from randomisation up to 12 weeks
3. Days on antibiotic therapy for treatment of infection from randomisation up to 12 weeks
4. Health economics - captured daily for the first 16 weeks post randomisation
5. Incidence of microbiologically proven infections, the pathogens and their susceptibility to antibiotics from randomisation up to 12 weeks
6. Number of days in hospital on antibiotics from randomisation up to 12 weeks
7. Number of clinically documented total infections, episodes of severe sepsis (CTCAE grade 3 or 4) from randomisation up to 12 weeks
8. Number of days in hospital from randomisation up to 12 weeks
9. Number of deaths and infection related deaths from randomisation up to 12 weeks
10. Overall survival at 1 year post randomisation
11. Patient characteristics, steroid usage and indices of immunocompetence from randomisation up to 12 weeks
12. Quality of life measured 4 weekly up to 16 weeks from randomisatio
13. Resonse to anti-myeloma therapy at 16 weeks. Because of the half life of paraproteins measurement of myeloma response cannot be under 16 weeks
14. Response to anti-myeloma therapy and its relationship to infection from randomisation up to 12 weeks
Overall study start date
01/09/2011
Overall study end date
31/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged minimum of 21 years and able to give informed consent
2. Patient with newly diagnosed symptomatic myeloma based on internationally agreed criteria, within 7 days of starting a programme of anti-myeloma therapy (or within 14 days of starting anti-myeloma therapy if already on a broad spectrum antibacterial agent)
3. Provision of written informed consent
4. Male or female participants
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: up to 1000; UK Sample Size: up to 1000
Total final enrolment
977
Participant exclusion criteria
1. Patients with contraindication to Levofloxacin:
1.1. Known to have sensitivity/allergy to Levofloxacin or other quinolones
1.2. Patients with a history of tendon disorders related to fluoroquinolone administration
1.3. Patients receiving other prophylactic antibiotic treatment (excluding pneumocystis prophylaxis if regarded as essential)
1.4. Patients receiving amiodarone or arsenic trioxide
1.5. Patients on active antiepileptic treatment
2. Women of childbearing age who are not willing to use appropriate methods of contraception to prevent pregnancy or women that are breastfeeding
3. Patient thought to have mandatory requirement for prophylactic antibiotics
4. Patient who is not going to receive anti myeloma therapy
Recruitment start date
13/04/2012
Recruitment end date
30/04/2016
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Department of Immunity and Infection
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
To be confirmed at a later date.
14/03/2018: Results were presented at the American Society for Hematology annual meeting 2017 https://ash.confex.com/ash/2017/webprogram/Paper106598.html
Intention to publish date
31/05/2018
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
The datasets generated and/or analysed during the current study are available on reasonable request from teamm@warwick.ac.uk, subject to approval from the trial management group and a data transfer agreement and contract.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/12/2019 | 04/11/2019 | Yes | No |
| Results article | results | 01/11/2019 | 08/11/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |