Double-blind, placebo-controlled study of nitazoxanide suspension in the treatment of cryptosporidiosis in children with HIV
| ISRCTN | ISRCTN41089957 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41089957 |
| Secondary identifying numbers | RM02-3013 |
- Submission date
- 10/06/2008
- Registration date
- 16/06/2008
- Last edited
- 15/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Kelly
Scientific
Scientific
Tropical Gastroenterology & Nutrition group
University of Zambia
School of Medicine
Lusaka
50398
Zambia
| Phone | +260 211 252269 |
|---|---|
| m.p.kelly@qmul.ac.uk |
Study information
| Study design | Double-blind, randomised, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | High dose prolonged treatment with nitazoxanide for the treatment of cryptosporidiosis in children with HIV: a double-blind, randomised placebo-controlled trial |
| Study objectives | The primary objective of the study is to evaluate the efficacy and safety of nitazoxanide oral suspension compared to a placebo in the treatment of cryptosporidiosis in children with HIV. |
| Ethics approval(s) | Research Ethics Committee of the University of Zambia, School of Medicine. Date of approval: 27/06/2002 (ref: 004-06-02) |
| Health condition(s) or problem(s) studied | HIV-related opportunistic infection/ cryptosporidiosis |
| Intervention | Nitazoxanide suspension: 200 mg twice a day (bid) for 28 days (if 1-3 years old) or 400 mg bid for 28 days (if 4-11 years old), or matching placebo. Total duration of follow-up: 4 weeks. However, a provision was included to allow compassionate open-label treatment for children who did not respond. This could have allowed extension of the period of follow-up by 60 days, therefore, it was possible for the children to be followed up for 88 days in total. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | nitazoxanide |
| Primary outcome measure | Proportion of children achieving 'well' clinical response and time to 'well' clinical response. Well response is defined as the patient experiencing no symptoms of C. parvum infection and passing no watery stools within the previous 48 hours. |
| Secondary outcome measures | 1. Proportion of children achieving eradication of oocysts of C. parvum from two consecutive stool samples, and time to eradication 2. Time to well clinical response and eradication of oocysts from the stool 3. Mortality at 4 weeks 4. Rate of reduction in diarrhoea frequency based on daily evaluation over 4 weeks 5. Nutritional response (change over time in weight for age z scores, weight for height z scores, height for age z scores and mid-upper arm circumference) based on daily evaluation over 4 weeks |
| Overall study start date | 01/06/2002 |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 11 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Both males and females, age 1-11 years 2. Stool positive for Cryptosporidium parvum using the auramine phenol staining technique (specimen collected within 7 days prior to enrolment) 3. Patients with diarrhoea (>= 3 unformed stools/day) for each of the 5 days prior to enrolment based on report by the patient, parent or guardian and observation in hospital for at least 24 hours 4. Patients who are HIV positive by the Capillus Rapid Test (Trinity Biotech, Ireland) |
| Key exclusion criteria | 1. Any investigational drug therapy within 1 month of enrolment 2. Use within 2 weeks of enrolment of metronidazole, tinidazole, ornidazole, secnidazole, hydroxyquinoline derivatives, diloxanide, paromomycin or nitazoxanide 3. Patients with positive enzyme immunoassay of faecal sample for Entamoeba histolytica or Giardia lamblia 4. Serious systemic disorders incompatible with the study |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- Zambia
Study participating centre
Tropical Gastroenterology & Nutrition group
Lusaka
50398
Zambia
50398
Zambia
Sponsor information
Romark Laboratories (USA)
Industry
Industry
6200 Courtney Campbell Causeway
Suite 880
Tampa
33607
United States of America
| Website | http://www.romark.com |
|---|---|
"ROR" |
https://ror.org/00982nx75 |
Funders
Funder type
Industry
Romark Laboratories (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/12/2009 | Yes | No |
