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

Completed

• Conditions: Severe acute malnutrition; Nutritional, Metabolic, Endocrine; Unspecified protein-energy malnutrition

• Registration Number: ISRCTN31079753
• Lead Sponsor: Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the peak plasma concentrations of ciprofloxacin. <br><br>Measured:<br>Group 1: at 2, 4, 8, 24 hours <br>Group 2: at 3, 5, 9, 12 hours <br>Group 3: at 1, 3, 6, 10 hours

Secondary Outcome Measures

Name	Time	Method
Define which co-variates influence the pharmacokinetics of ciprofloxacin in this group of patients:<br>1. Age, assessed on admission (0 hour)<br>2. Sex, assessed on admission (0 hour)<br>3. Anthropometric indices, assessed on admission (0 hour)<br>4. Haemodynamic status, measured at 0 hour and 48 hour<br>5. Concomitant medications, reviewed every 4 hours