Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in At Tur Bani Qa'is, Harad, Almusaymir, Jabal Ash Sharq, Al Udayn and Bajil districts in Yemen

Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Yemen

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000696099

Enrollment

522

Registered

2010-08-24

Start date

2009-11-08

Completion date

2011-02-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study assesses the efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in The participants will be febrile patients aged 6 months and above with confirmed uncomplicated P. falciparum infection. Artesunate (4mg/kg over 3 days) co-administered with sulfadoxine/pyrimethamine (single dose of 25mg sulfadoxine/1.25mg pyrimethamine per kg on day 0) will be tested in four of the sites and artemether-lumefantrine (a 6-dose regimen of artemether-lumefantrine twice a day for 3 days) in the other two sites. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from November 2009 to April 2010.

Interventions

One-arm propective evaluation with: (a) artesunate+sulfadoxine/pyrimethamine combination therapy in 4 sites (Al Tor beni Qais, Harad, Almosaimeer, Al Odein) and (b) artemether-lumefantrine combination therapy in two sites (Jabal Al Sharq and Bajil). Dose regimen: (a) artesunate+sulfadoxine/pyrimethamine tablets: artesunate 4 mg/kg body weight (bw) per day for 3 days plus a single dose of 25/1.25 mg/kg bw of sulfadoxine/ pyrimethamine. (b) artemether-lumefantrine tablets (tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrine twice a day for 3 days according to the following weigth bands: 5-14 kg bw: 1 tablet; 15-24 kg bw: 2 tablets; 25-34 kg bw: 3 tablets and =35 kg bw: 4 tablets. All treatment will be orally taken tablets

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

6 Months to No maximum

Healthy volunteers

Inclusion criteria

1. age 6 months and above; 2. mono-infection with Plasmodium falciparum (P.falciparum) detected by microscopy; 3. parasitaemia of 500-200000/microliter asexual forms; 4. presence of axillary temperature less than or equal to 37.5 degrees centigrade; 5. ability to swallow oral medication; 6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and 7. informed consent from the patient or from a parent or guardian in the case of children.

Exclusion criteria

1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization (WHO). 2. mixed or mono-infection with another Plasmodium species detected by microscopy; 3. presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference <110 mm); 4. presence of febrile conditions 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 and hepatic diseases, Human immunodeficiency virus/Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (HIV/AIDS); 5. regular medication, which may interfere with antimalarial pharmacokinetics; 6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 7. unmarried women of child-bearing age; 8. a positive pregnancy test or breastfeeding; 9. unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age.

Outcome results