Summary of findings 5. Inhaled colistin plus oral ciprofloxacin compared to inhaled tobramycin plus oral ciprofloxacin.
| Inhaled colistin plus oral ciprofloxacin compared to inhaled tobramycin plus oral ciprofloxacin for eradicating Pseudomonas aeruginosa in people with cystic fibrosis | ||||||
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Patient or population: adults and children with cystic fibrosis and a positive microbiological isolate of P aeruginosa from a respiratory tract specimen Settings: outpatients Intervention: inhaled colistin plus oral ciprofloxacin Comparison: inhaled tobramycin plus oral ciprofloxacin | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Inhaled tobramycin plus oral ciprofloxacin | Inhaled colistin plus oral ciprofloxacin | |||||
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Eradication of P aeruginosa from the respiratory tract: proportion with positive respiratory culture for P aeruginosa Follow‐up: median 16 months |
315 per 1000 | 403 per 1000 (227 to 721 per 1000) |
OR 1.28 (95% CI 0.72 to 2.29) | up to 2231 (1 RCT) | ⊕⊕⊝⊝ low2,3 | There was also no significant difference between treatment groups within the first 6 months, OR 1.11 (95% CI 0.64 to 1.92). |
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FEV₁: relative change in % predicted FEV1 from baseline Follow‐up: mean 54 days |
The mean relative change in % predicted FEV₁ from baseline was 4.55% in the inhaled tobramycin plus oral ciprofloxacin group. | The mean relative change in % predicted FEV₁ from baseline was 2.4% lower (5.89% lower to 1.09% higher) in the inhaled colistin plus oral ciprofloxacin group. | NA | 1281 (1 RCT) |
⊕⊕⊝⊝ low2,4 | |
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FVC Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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Growth and nutritional status Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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Frequency of infective pulmonary exacerbations: number of exacerbations per patient year Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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Isolation of other micro‐organisms from the respiratory tract: number of positive cultures per patient year Follow‐up: median 16 months |
There were no differences during follow up between the two groups for isolation of: Stenotrophomonas maltophilia, Achromobacter xylosoxidans or Aspergillus species. | NA | 2051 (1 RCT) | ⊕⊕⊕⊝ moderate2 | ||
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Adverse effects to antibiotics: leading to trial discontinuation Follow‐up: median 16 months |
21 out of 118 (18%) participants discontinued the trial early due to adverse events in the inhaled tobramycin plus oral ciprofloxacin group. | 17 out of 105 (16%) participants discontinued the trial early due to adverse events in the inhaled colistin plus oral ciprofloxacin group. | NA | 223 (1 RCT) | ⊕⊕⊕⊝ moderate2 | Reasons for discontinuations included vomiting, photosensitivity, wheeze and pulmonary exacerbation. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; FEV₁: forced expiratory volume in one second; FVC: forced vital capacity; NA: not applicable; NR: not reported OR: odds ratio; P aeruginosa: Pseudomonas aeruginosa; RCT: randomised controlled trial | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1. In the included trial, 223 participants were randomised but not all participants contributed to all outcomes (unclear how many participants contributed to some outcomes, spirometry not performed in very young children).
2. Downgraded once due to risk of bias; methodological information was limited and unclear in the included study and there were potential concerns of bias due to selective reporting of results and lack of blinding.
3. Downgraded once due to imprecision: wide confidence intervals around the effect size.
4. Downgraded once due to applicability: a large proportion of the randomised participants (95 out of 223, 42%) did not contribute to this outcome.