Research Assesses Treatment Of Lung Infections In Patients With Cystic Fibrosis24 Apr 2009
New research commissioned by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme will assess the clinical and cost-effectiveness of methods used to treat lung infections caused by an organism called Pseudomonas aeruginosa (P. aeruginosa) in children and adults with cystic fibrosis. Cystic fibrosis affects over 8,000 people in the UK and is the most common life-threatening inherited disease in the Caucasian population, with one in 25 people in the UK carrying the gene.
Cystic fibrosis is a multi-system disease which has particular effects on the pancreas and lungs, clogging them with thick, sticky mucus. Children and adults with cystic fibrosis are prone to chest infections and these infections can cause long-term damage to the lungs, affecting the health and long-term survival of the patient. There are a number of different organisms that cause these infections, with P. aeruginosa one of the most common. It is usually treated with a combination of oral, intravenous and nebulised antibiotics, but at present it is not possible to determine the best method to eradicate it and delay chronic infection.
Researchers, led by Dr Simon Langton Hewer of the University Hospitals Bristol NHS Foundation Trust, will carry out this £1 million multi-centre randomised controlled trial comparing ten days of intravenous therapy to three months of oral therapy. Cystic fibrosis patients who have isolated P. aeruginosa will be recruited from 20 collaborating centres throughout the UK.
Patients will be randomised to receive either ten days of intravenous therapy or three months of oral therapy, with both groups also receiving three months of nebulised antibiotics. The main outcome measure will be the successful eradication of P. aeruginosa infection at three months after receiving treatment, and remaining infection free through to 15 months after treatment. Other outcome measures will include: the time it takes for the P. aeruginosa infection to recur, or for a new infection to occur; lung function; growth and nutritional status; number of pulmonary exacerbations; admissions to hospital; number of days spent as an inpatient; quality of life; adverse events; re-infection with a different strain of Pseudomonas; other sputum/cough microbiology; yeast infection; cost-effectiveness; and carer burden.
"Despite there being substantial differences to the patient and family in terms of what these two treatment choices offer, at present it is not possible for medical teams to say if intravenous treatment is better than oral treatment in its ability to totally clear the infection from the body," says Dr Langton Hewer. "If the use of intravenous antibiotics has the capacity to delay or prevent colonisation of P. aeruginosa more effectively than standard oral treatments, it could lead to a reduction in respiratory morbidity and mortality, and result in improvements in quality of life for patients. Equally, if oral treatment is not significantly less effective than intravenous then patients may be safely treated at home and without the need for hospital admission."
University of Southampton
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