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Elective Antibiotics for Cystic Fibrosis

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					Elective Antibiotics for
   Cystic Fibrosis




                   Esther Sim
          Summary of Case
 CW, a 15 year old girl with cystic fibrosis
 Multiple admissions (current is 64th)
 Pseudomonas Aeruginosa colonised
 Just started on regular 6/52 admissions for
  “tune ups”
             Clinical Question
   What is the evidence for “tune up”
    admissions?

OR (in EBM language)

   Do elective admissions for antibiotics in
    CF patients result in an improved clinical
    status?
                 PICO Format
 P = Cystic Fibrosis patients
 I = Elective admission for antibiotics
 C = Symptomatic admission for antibiotics
 O = Improvement in clinical status
          Lung function
          Hospitalisations
          Exacerbations
          Survival
          Searching for Evidence
   Cochrane Library
       Search string: “Cystic fibrosis AND antibiotic
        AND (elective OR prophylactic)”
               3 hits



   PubMed
       Search string: “Cystic fibrosis AND antibiotic
        AND (elective OR prophylactic)”
               41 hits
           Systematic Review
   Breen L, Aswani N. Elective versus
    symptomatic intravenous antibiotic therapy
    for cystic fibrosis. Cochrane Database of
    Systematic Reviews 2001, Issue 4. Art.
    No.: CD002767. DOI:
    10.1002/14651858.CD002767.


                 JACKPOT! Or so I thought…
     Not all that glitters is gold…
   Comprehensive and thorough search
    strategy
     Cochrane Trials register, MEDLINE, EMBASE
     Yielded 4 studies



   2 studies excluded as did not met
    inclusion criteria
        1  compared inhaled Vs IV antibiotics
         1 abstract compared single Vs combination
          antibiotics
                            Hmm….
   2 studies included in final analysis (n = 79)
       Brett 1992 – looked at effect of value of serum
        IgG titres against P aeruginosa
                  N = 19


       Elborn 2000 – compared elective Vs
        symptomatic antibiotics
                  N = 60
           Study – Elborn 2000
   Elborn J et al; Elective versus symptomatic
    antibiotic treatment in cystic fibrosis patients with
    chronic Pseudomonas infection of the lungs;
    2000; Thorax 55(5):355-358.
 Was the assignment of patients to
     treatments randomised?
 Central coordinating centre
 Randomised to
       Elective antibiotics – every 3 months
               10-14 days with antipseudomal antibiotics
       Symptomatic antibiotics – when needed

   Minimisation method to allocate
          Age, severity based on chest radiographic score,
           treatment centre
          ? Pseudo-randomisation
Were the groups similar at the start
           of the trial?
    Were the groups treated equally?

                            Elective antibiotic     Symptomatic
                                                    antibiotic
Nebulised                   25%                     40%
antibiotics
Regular inhaled             41%                     29%
bronchodilators

   Anti-staphylococcal antibiotics
   Prevalence of other CF complications
                 Pancreatic insufficiency, DM, significant renal or liver
                  disease, ABPA, B cepacia infection, Hx of pneumothorax
    Were all patients who entered the
          trial accounted for?
   Yes
       4   deaths and 5 withdrawals in Elective group
               3 – inconvenience of regular AB Rx
               1 – heart-lung transplant
               1 - pregnant
       1   withdrawal in Symptomatic group
               “at patient’s request”
        All    deaths due to respiratory failure


   Analysed according to “Intention to treat”
    Is the study double blinded?
   No
       But the study question prevented this
                   Results
   Antibiotic treatments
                  Results
   Clinical Outcomes
Results
                              Results
   Sputum microbiology
       No difference in prevalence of S aureus & H influenzae
   No evidence of increased antibiotic resistant
    Pseudomonas
   Survival
       Continued to collect data for further 5 years
       8 deaths in elective group
       1 death in symptomatic group
               Elective Rx associated with decreased survival?
    How precise were the treatment
               effects?
   Target sample size was 100 patients
       Recruited 60 patients
       May be reason why ‘trends’ in clinical outcomes did not
        reach statistical significance
        Can I apply this to CW?
 Age
 Is treatment feasible?
     Cost
     Access

   Does this paper support regular
    admissions for ‘tune ups’ in adolescent CF
    patients?

				
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posted:12/11/2011
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