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A study of the concentration of ciprofloxacin in the body over time when given by mouth

Population pharmacokinetics of oral ciprofloxacin in children with severe malnutrition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31079753
Enrollment
52
Registered
2008-06-10
Start date
2008-06-09
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute malnutrition Nutritional, Metabolic, Endocrine Unspecified protein-energy malnutrition

Interventions

Current information as of 02/02/2009: In 36 children, ciprofloxacin will be given 2 hours after the child has received his/her first feed and medication. 16 children will have ciprofloxacin administer

Sponsors

Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026