Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00393744

Purpose

The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.

Condition	Intervention	Phase
Tonsillitis	Drug: pristinamycin Drug: amoxicillin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years.

Resource links provided by NLM:

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

bacterial eradication [ Time Frame: at V3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

adverse events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Enrollment:	395
Study Start Date:	October 2006
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pristinamycin 50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
2: Active Comparator	Drug: amoxicillin 50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days

Eligibility

Ages Eligible for Study:	6 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

subjects of both sexes
aged between 6 and 25 years,
weight : ≥ 20kg
with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable satellite adenopathy)
confirmation by positive RDT
provision of throat swabs for culture
ability to swallow tablets

Exclusion Criteria:

Related to the study disease:
- suspected viral infection (concomitant dysphonia, cough, conjunctivitis, rhinitis)
- adenophlegmon, peritonsillar abscesses.
Related to the study treatment:
- known or suspected allergy to beta-lactamines (penicillin, cephalosporin)
- suspected infectious mononucleosis (increased risk of skin disorders)
- phenylketonuria (due to the presence of aspartame)
- congenital galactosaemia, glucose/galactose malabsorption syndrome, lactase deficiency (due to the presence of lactose, in powder or suspension form)
- allergy to pristinamycin and/or virginiamycin
- history of pustular rash with pristinamycin
- hypersensitivity or gluten intolerant (due to the presence of wheat starch)
- ongoing treatment with cyclosporine, methotrexate, colchicine, allopurinol, tacrolimus or oral anticoagulants.
Related to previous treatment:
- subjects receiving antibiotic therapy in the month prior to inclusion, except for azithromycin, for which the exclusion period is 3 months.
- subjects on short-term corticosteroids. Subjects on long-term corticosteroids initiated before the start of the study and taken at a controlled dosage may be included.
Related to subjects:
- breast-feeding women
- women either pregnant or attempting to conceive
- subjects likely, during the course of the study to receive treatments prohibited by the protocol
- treatment with other investigational drugs in the 4 weeks prior to inclusion in the study
- immunodepression, clinically significant endocrine disease, cardiovascular disease, neurological disease, or any other marked diseases resulting in complications in performance of the study or interpretation of the study data
- known hepatic impairment
- known renal impairment (creatinine clearance < 30 ml/minute)
- cancer, blood dyscrasias
- previous history of drug or alcohol abuse.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393744

Locations

France
Sanofi-aventis
Paris, France

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Marie SEBILLE, Dr

Sanofi-Aventis

More Information

Additional Information:

CSR synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	PRIST_L_01683, EudraCT #: 2006-002127-16
Study First Received:	October 27, 2006
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00393744 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Amoxicillin
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Therapeutic Uses
Tonsillitis
Stomatognathic Diseases
Pristinamycin
Pharyngeal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010