Condition category
Cancer
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
08/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Kerry Raynes

ORCID ID

Contact details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

2011-000366-35

ClinicalTrials.gov number

Protocol/serial number

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

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

Trial setting

GP practices

Trial 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

Phase

Not Applicable

Drug names

Levofloxacin

Primary outcome measures

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 trial start date

01/09/2011

Overall trial end date

31/05/2017

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: up to 1000; UK Sample Size: up to 1000

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/

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

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

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.

Intention to publish date

01/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/11/2016: the following changes were made to the trial record: 1. The overall trial start date was changed from 01/11/2011 to 01/09/2011. 2. The overall trial end date was changed from 30/11/2015 to 31/05/2017. 3. The target number of participants was changed from 800 to 1000.