Summary of findings 3. Oral ciprofloxacin and inhaled colistin compared to inhaled tobramycin.
| Oral ciprofloxacin and inhaled colistin compared to inhaled tobramycin 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: oral ciprofloxacin and inhaled colistin Comparison: inhaled tobramycin | ||||||
| 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 | Oral ciprofloxacin and inhaled colistin | |||||
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Eradication of P aeruginosa from the respiratory tract: Proportion with positive respiratory culture for P aeruginosa Follow‐up: up to 24 months |
458 per 1000 | 348 per 1000 (110 to 1000 per 1000) |
OR 0.76 (95% CI 0.24 to 2.42) | up to 581 (1 RCT) | ⊕⊝⊝⊝ very low2,3,4 | There was also no significant difference between treatment groups within the first 6 months, OR 0.43 (95% CI 0.15 to 1.23). |
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FEV₁: change from baseline (% predicted) Follow‐up: up to 24 months |
Median change from baseline in FEV₁ (% predicted) for all the participants was ‐1%. | NR | up to 581 (1 RCT) | ⊕⊝⊝⊝ very low2,3,5 | Changes in FEV₁ are not reported separately for each treatment arm. | |
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FVC Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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Growth and nutritional status: BMI and weight z score Follow‐up: up to 24 months |
Both BMI z score and weight z score were reported not to have changed significantly for trial participants as a whole. | NR | up to 581 (1 RCT) | ⊕⊝⊝⊝ very low2,3,5 | Numerical data were not reported for comparative results across the treatment groups. | |
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Frequency of infective pulmonary exacerbations: number of exacerbations per patient year Follow‐up: up to 24 months |
During the first six months of follow up, there was no difference between the two treatment arms in number of oral antibiotic treatment days. | NR | up to 581 (1 RCT) | ⊕⊝⊝⊝ very low2,3,5 | These oral antibiotics were given for symptoms and not because of failed eradication. No numerical data were reported |
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Isolation of other micro‐organisms from the respiratory tract: number of positive cultures per patient year Follow‐up: NA |
Outcome not reported. | NA | NA | NA | ||
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Adverse effects to antibiotics: severe cough Follow‐up: up to 24 months |
34 per 1000 | 11 per 1000 (0 to 280 per 1000) |
OR 0.32 (95% CI 0.01 to 8.24) | up to 581 (1 RCT) | ⊕⊝⊝⊝ very low2,3,4 | No other specific adverse events were reported. |
| *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). BMI: body mass index; 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, 58 participants were randomised but not all participants contributed to all outcomes (unclear how many participants contributed to some outcomes).
2. Downgraded once due to risk of bias; methodological information was limited and unclear in the included study and there were concerns of bias due to selective reporting of results.
3. Downgraded once due to applicability: the included studies recruited only children; results are not applicable to adults.
4. Downgraded once due to imprecision: very wide confidence intervals around the effect size.
5. Downgraded once due to imprecision: no numerical comparative results available.