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ISRCTN
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ISRCTN31079753
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ClinicalTrials.gov identifier
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Public title
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Population pharmacokinetics of oral ciprofloxacin in children with severe malnutrition
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Scientific title
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Acronym
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N/A
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Serial number at source
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077092
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Study hypothesis
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Mortality among children with severe malnutrition has remained high especially for those with proven bacteraemia. The currently recommended antibiotics offer sub-optimal cover for gram negative infections. Ciprofloxacin has good gram negative cover and can be given as an oral formulation owing to its good oral bioavailability over norfloxacin and good tissue penetration, which give concentrations that are at least equivalent to the minimum inhibitory concentration designated as the breakpoint of bacterial susceptibility in vitro.
It has been used widely in children with cystic fibrosis and immunocompromised children without any significant toxicity. The previous cost of the newer generations of oral quinolones was prohibitive and so pharmacokinetics (PK) in such populations could not be justified on the basis of limited application. The availability of cheaper formulations of the oral quinolones coupled with poor prognosis of children with severe malnutrition and gram negative infection on current standard treatment support the value of this study. No studies have been done on the PK of ciprofloxacin in children with severe malnutrition. This will provide a model to predict PK of ciprofloxacin in this group. Again this data will assist with the future national and international treatment guidelines for children with severe malnutrition.
Please note that as of 06/08/2008 the public title of this trial has changed to the above, and the scientific title has been removed. The previous public and scientific titles were:
Previous public title: A study of the concentration of ciprofloxacin in the body over time when given by mouth
Previous scientific title: Population pharmacokinetics of oral ciprofloxacin in children with severe malnutrition
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Ethics approval
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Ethics approval received from the Kenya Medical Research Institute (KEMRI) Ethical Review Committee (ERC) on the 27th March 2008 (Scientific Steering Committee [SSC] ref: 1331).
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Study design
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Single centre, single arm, non-randomised, population PK trial
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Severe acute malnutrition
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Participants - inclusion criteria
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1. Aged over 6 months, either sex
2. Consent given
3. Severe malnutrition as defined by weight-for-height Z score (WHZ) less than -3 or bilateral oedema (of kwashiorkor) or mid-upper arm circumference (MUAC) less than 11.0 cm (if greater than 65 cm in length)
4. Able to take and retain oral treatment
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Participants - exclusion criteria
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1. Admission plasma creatinine greater than 300 and evidence of intrinsic renal disease (hypertension or hyperkalaemia)
2. Coexisting bone or joint disease
3. Concurrent use of antacids, ketoconazole, theophylline, corticosteroids
4. Enrolment in another interventional study
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Anticipated start date
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09/06/2008
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Anticipated end date
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26/03/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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36
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Interventions
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Children will be divided into three groups based on severity. From each group there will be three subgroups for sampling times for four samples. Patients will be given ciprofloxacin orally, 10 mg/kg, twice daily for two days.
The children will be reviewed daily until they are disharged and then on day 28.
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Primary outcome measure(s)
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Determine the peak plasma concentrations of ciprofloxacin.
Measured:
Group 1: at 2, 4, 8, 24 hours
Group 2: at 3, 5, 9, 12 hours
Group 3: at 1, 3, 6, 10 hours
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Secondary outcome measure(s)
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Define which co-variates influence the pharmacokinetics of ciprofloxacin in this group of patients:
1. Age, assessed on admission (0 hour)
2. Sex, assessed on admission (0 hour)
3. Anthropometric indices, assessed on admission (0 hour)
4. Haemodynamic status, measured at 0 hour and 48 hour
5. Concomitant medications, reviewed every 4 hours
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Sources of funding
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Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya) (ref: 077092)
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Trial website
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Publications
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Contact name
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Dr
Nahashon
Thuo
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Address
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P.O. Box 230
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City/town
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Kilifi
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Zip/Postcode
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80108
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Country
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Kenya
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Sponsor
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Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya)
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Address
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P.O. Box 230
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City/town
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KIlifi
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Zip/Postcode
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80108
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Country
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Kenya
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Sponsor website:
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http://www.kemri-wellcome.org
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Date applied
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03/06/2008
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Last edited
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06/08/2008
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Date ISRCTN assigned
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10/06/2008
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