ISRCTN20984426
Completed
未知
A randomised study to assess the efficacy and tolerability of three Artemisinin-based combination therapy (ACT) in The Democratic Republic of Congo (DRC)
The Centre for Tropical Medicine (UK)0 sites684 target enrollmentOctober 6, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- The Centre for Tropical Medicine (UK)
- Enrollment
- 684
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children aged 3 to 59 months
- •2\. Weight \= 5 kg \[the minimum weight for treatment with artemether\-lumefantrine (ALN)]
- •3\. Mono\-infection with P. falciparum
- •4\. Parasitaemia of \=2,000 and \=200,000 asexual parasites per µL
- •5\. Axillary temperature 37\.5 °C or history of fever in the preceding 24 hrs
- •6\. Ability to swallow oral medication
- •7\. Haemoglobin \=5\.0 g/dL
- •8\. Parents/guardians agree to hospitalize the child for the length of treatment (34 days) and bring the patient for planned follow\-up visits at day 7, 14, 21, 28, 35, 42
- •9\. Signed consent from guardian / parents
Exclusion Criteria
- •1\. Danger signs of severe malaria or signs of severe malaria (WHO 2000\)
- •2\. Children with severe malnutrition, marasmus or oedematous malnutrition (WHO 2006\)
- •3\. Febrile condition due to diseases other than malaria \[e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, human immunodeficiency virus (HIV) / acquired immune deficiency syndrome (AIDS)]
- •4\. History of hypersensitivity reactions or contraindication to any medicine being tested
- •5\. A clear history of adequate antimalarial treatment in the preceding 72 hours with drugs expected to be effective
- •6\. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV positive women
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study to investigate the efficacy and safety of L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcomaEUCTR2018-004104-19-DEPhilogen S.p.A.98
Active, not recruiting
Phase 1
A study to investigate the efficacy and safety of L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcomanresectable and/or metastatic soft-tissue sarcoma after failure of at least two prior systemic therapy regimensMedDRA version: 20.0Level: PTClassification code 10075333Term: Soft tissue sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-004104-19-ESPhilogen S.p.A.98
Active, not recruiting
Phase 1
A study to investigate the efficacy and safety of L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcomaEUCTR2018-004104-19-ITPHILOGEN S.P.A.98
Active, not recruiting
Phase 1
A study to investigate the efficacy and safety of L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcomaEUCTR2018-004104-19-PLPhilogen S.p.A.98
Active, not recruiting
Phase 1
Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcomanresectable and/or metastatic soft-tissue sarcoma after failure of at least two prior systemic therapy regimens.MedDRA version: 20.0Level: PTClassification code: 10075333Term: Soft tissue sarcoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]CTIS2024-512704-20-00Philogen S.p.A.98