- Trials with a EudraCT protocol (52)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (94)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: Once daily cefixime compared with twice daily trimethoprim / sulfamethoxazole for treatment of urinary tract infection in infants and children - Etude Dagan R. et col. - 1992 (Pediatr. Infect. Dis. J. 11: 198 - 203)Once daily cefixime compared with twice daily trimethoprim / sulfamethoxazole for treatment of urinary tract infection in infants and children - Etude Dagan R. et col. - 1992 (Pediatr. Infect. Dis. J. 11: 198 - 203) |
Active substance: CEFIXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23424 |
Study title: Once daily cefixime compared with twice daily trimethoprim/sulfamethodaxole for treatment of urinary tract infections in infants and children (Pediatr Infect DIs KJ 1992; 11: 198-203); Once daily cefixime compared with twice daily trimethoprim/sulfamethodaxole for treatment of urinary tract infections in infants and children (Pediatr Infect DIs KJ 1992; 11: 198-203); |
Active substance: CEFIXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23423 |
Study title: Cefpodoxime proxetil Pediatric suspension (8 mg / ml) Extension of indications UTI / SSTI: comparison of cefpodoxime proxetil oral suspension (100 mg / 5 ml) vs trimethoprim / sulfamethoxazole in the treatment of uncomplicated urinary tract infections in infants and children TR n° 9155 - 90 - 001 / M - 1140 - 0020 - No author - 1991Cefpodoxime proxetil Pediatric suspension (8 mg / ml) Extension of indications UTI / SSTI: comparison of cefpodoxime proxetil oral suspension (100 mg / 5 ml) vs trimethoprim / sulfamethoxazole in the treatment of uncomplicated urinary tract infections in infants and children TR n° 9155 - 90 - 001 / M - 1140 - 0020 - No author - 1991 |
Active substance: CEFPODOXIME |
Study summary document link (including results): |
View full study record |
Document reference: 23559 |
Study title: Comparison of Cefpodoxime Proxetil Oral Suspension vs Trimethoprim/Sulfamethoxazole Oral Suspension in the Treatment of Uncomplicated Urinary Tract Infections |
Active substance: CEFPODOXIME |
Study summary document link (including results): CEFPODOXIME STUDY TR915590001.xls |
View full study record |
Document reference: 47969 |
Study title: Comparative trial of erythromycin and sulphatrimethoprim in the treatment of tetracycline−resistant Vibrio cholerae O1. Burans JP, Podgore J, Mansour MM, Farah AH, Abbas S, Abu Elyazeed R, Woody JN. Transactions of the Royal Society of Tropical Medicine and Hygiene, Nov−Dec 1989, vol. 83, no. 6, p. 836−8. |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 26497 |
Study title: Double−blind comparative trial of trimethoprim/sulfamethopyrazine once daily vs erythromycin 4 X daily in patients with ENT infections. Federspil P, Koch J. International journal of clinical pharmacology therapy and toxicology, Oct 1983, vol. 21, no. 10, p. 535−9, ISSN: 0174−4879. |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 26527 |
Study title: Efficacy of trimethoprim sulfamethoxazole compared with sulfadoxine pyrimethamine plus erythromycin for the treatment of uncomplicated malaria in children with integrated management of childhood illness dual classifications of malaria and pneumonia.Hamel Mary J, Holtz Timothy, Mkandala Christopher, Kaimila Nyokase, Chizani Nyson, Bloland Peter, Kublin James, Kazembe Peter, Steketee Richard. The American journal of tropical medicine and hygiene, Sep 2005, vol. 73, no. 3, p. 609 15, |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 26421 |
Study title: Final Study Report: A Comparative Study of Single-Dose Intramuscular (IM) Ceftriaxone Versus Single-Dose IM Bicillin CR plus Oral Trimethoprim-Sulfamethoxazole for the Treatment of Uncomplicated Acute Otitis Media in Infants and Children (Howie Protocol) |
Active substance: CEFTRIAXONE |
Study summary document link (including results): |
View full study record |
Document reference: 23613 |
Study title: Trimethoprim-polymyxin B sulphate ophthalmic ointment in the treatment of bacterial conjunctivitis: a double-blind study versus chloramphenicol ophthalmic ointment. Behrens-Baumann W, Quentin CD, Gibson JR, Calthrop JG, Harvey SG, Booth K. Curr Med Res Opin. 1988;11(4):227-31. Trimethoprim-polymyxin B sulphate ophthalmic ointment in the treatment of bacterial conjunctivitis: a double-blind study versus chloramphenicol ophthalmic ointment. Behrens-Baumann W, Quentin CD, Gibson JR, Calthrop JG, Harvey SG, Booth K. Curr Med Res Opin. 1988;11(4):227-31. |
Active substance: CHLORAMPHENICOL_ CHLORAMPHENICOL +CORTISONE ACETATE +ETHACRIDINE LACTATE +ZINC OXIDE / CHLORAMPHENICOL AND MEDROXYPROGESTERONE AND TETRYZOLINE |
Study summary document link (including results): Trimethoprim-polymyxin B sulphate ophthalmic ointment in the.pdf |
View full study record |
Document reference: 23865 |
Study title: Trimethoprim-polymyxin B sulphate ophthalmic ointment versus chloramphenicol ophthalmic ointment in the treatment of bacterial conjunctivitis--a review of four clinical studies. The Trimethoprim-Polymyxin B Sulphate Ophthalmic Ointment Study Group. [No authors listed] J Antimicrob Chemother. 1989 Feb;23(2):261-6.Trimethoprim-polymyxin B sulphate ophthalmic ointment versus chloramphenicol ophthalmic ointment in the treatment of bacterial conjunctivitis--a review of four clinical studies. The Trimethoprim-Polymyxin B Sulphate Ophthalmic Ointment Study Group. [No authors listed] J Antimicrob Chemother. 1989 Feb;23(2):261-6. |
Active substance: CHLORAMPHENICOL_ CHLORAMPHENICOL +CORTISONE ACETATE +ETHACRIDINE LACTATE +ZINC OXIDE / CHLORAMPHENICOL AND MEDROXYPROGESTERONE AND TETRYZOLINE |
Study summary document link (including results): Trimethoprim-polymyxin B sulphate ophthalmic ointment.pdf |
View full study record |
Document reference: 23866 |
Study title: Trimethoprim-polymyxin ophthalmic solution versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis. van Rensburg SF, Gibson JR, Harvey SG, Burke CA. Pharmatherapeutica. 1982;3(4):274-7.Trimethoprim-polymyxin ophthalmic solution versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis. van Rensburg SF, Gibson JR, Harvey SG, Burke CA. Pharmatherapeutica. 1982;3(4):274-7. |
Active substance: CHLORAMPHENICOL_ CHLORAMPHENICOL +CORTISONE ACETATE +ETHACRIDINE LACTATE +ZINC OXIDE / CHLORAMPHENICOL AND MEDROXYPROGESTERONE AND TETRYZOLINE |
Study summary document link (including results): Trimethoprim-polymyxin ophthalmic solution versus.pdf |
View full study record |
Document reference: 23858 |
Study title: A prospective, randomized study to compare ciprofloxacin (either as oral suspension or as IV or sequential IV oral suspension therapy) versus control regimens (either trimethoprim/ sulfamethoxazole oral suspension, cefixime oral suspension, IV ceftazidime, sequential IV ceftazidime trimethoprim/ sulfamethoxazole oral suspension therapy or sequential IV ceftazidime PO cefixime) in the treatment of pediatric patients with complicated urinary tract infections or pyelonephritis. |
Active substance: CIPROFLOXACIN |
Study summary document link (including results): Bayer Pharma_Ciprofloxacin_100169_study_synopsis.pdf |
View full study record |
Document reference: 24204 |
Study title: Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections. Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8. Trimethoprim-polymyxin B ophthalmic solution in treatment of surface ocular bacterial infections. Nozik RA, Smolin G, Knowlton G, Austin R. Ann Ophthalmol. 1985 Dec;17(12):746-8. |
Active substance: DEXAMETHASONE AND NEOMYCIN |
Study summary document link (including results): |
View full study record |
Document reference: 25748 |
Study title: A bacteriological study of the middle ear and upper respiratory tract in children with chronic secretory otitis media.Mills et al., Clin Otolaryngol Allied Sci. 1985 Dec;10(6):335-41A bacteriological study of the middle ear and upper respiratory tract in children with chronic secretory otitis media.Mills et al., Clin Otolaryngol Allied Sci. 1985 Dec;10(6):335-41 |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): |
View full study record |
Document reference: 46818 |
Study title: A clinical and therapeutic study of 29 patients with infantile acne.Cunliffe et al., Br J Dermatol. 2001 Sep;145(3):463-6.A clinical and therapeutic study of 29 patients with infantile acne.Cunliffe et al., Br J Dermatol. 2001 Sep;145(3):463-6. |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): |
View full study record |
Document reference: 46793 |
Study title: Paediatric nosocomial urinary tract infection at a regional hospital.Orrett et al., Int Urol Nephrol. 1999;31(2):173-9Paediatric nosocomial urinary tract infection at a regional hospital.Orrett et al., Int Urol Nephrol. 1999;31(2):173-9 |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): |
View full study record |
Document reference: 46799 |
Study title: Positive correlation between the age of patients and the degree of antimicrobial resistance among urinary strains of Escherichia coli.Arstila et al., J Infect. 1994 Jul;29(1):9-16Positive correlation between the age of patients and the degree of antimicrobial resistance among urinary strains of Escherichia coli.Arstila et al., J Infect. 1994 Jul;29(1):9-16 |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): |
View full study record |
Document reference: 46804 |
Study title: Prenatally diagnosed reflux: a follow-up study.Gordon et al., Br J Urol. 1990 Apr;65(4):407-12Prenatally diagnosed reflux: a follow-up study.Gordon et al., Br J Urol. 1990 Apr;65(4):407-12 |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): |
View full study record |
Document reference: 46809 |
Study title: Presence of bacteriuria caused by trimethoprim resistant bacteria in patients prescribed antibiotics: multilevel model with practice and individual patient data.Donnan et al., BMJ. 2004 May 29;328(7451):1297Presence of bacteriuria caused by trimethoprim resistant bacteria in patients prescribed antibiotics: multilevel model with practice and individual patient data.Donnan et al., BMJ. 2004 May 29;328(7451):1297 |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): |
View full study record |
Document reference: 46779 |
Study title: Prevalence of carriage of antimicrobial resistant strains of Streptococcus pneumoniae in primary school children in Hong Kong.Boost MV et al., Epidemiol Infect. 2001 Aug;127(1):49-55Prevalence of carriage of antimicrobial resistant strains of Streptococcus pneumoniae in primary school children in Hong Kong.Boost MV et al., Epidemiol Infect. 2001 Aug;127(1):49-55 |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): |
View full study record |
Document reference: 46792 |