Amodiaquine Plus Artesunate Versus Lapdap Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi

Malaria, Falciparum Clinical Trial

Official title:

A Double-blind Randomised Trial to Assess the Tolerability of Amodiaquine Plus Artesunate (AQ-Art) Versus Chlorproguanil Plus Dapsone Plus Artesunate (CDA) in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164359
• Other study ID #: CDC-NCID-4538
• Secondary ID: PA#04018
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: September 26, 2012
• Start date: April 2005
• Est. completion date: September 2005

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to an imminent need for the government of Malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new therapy as policy. This protocol is the second of two protocols whose combined purpose is to provide efficacy and side effect data on four antimalarial drug combinations that are candidates for the next first-line therapy for uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry in 1995 because of a perceived association with abdominal pain. Although no studies were conducted to substantiate this, consensus among clinicians was that patients were refusing amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was removed from the registry. Results from this study, along with the efficacy data from the sister protocol in children under five years of age, will help guide the National Malaria Control Program of Malawi in selecting their next first-line antimalarial therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Age five years or older

• Axillary temperature >= 37.5 degrees Celsius

• Monoinfection with P. falciparum

• Parasitemia between 2000 and 200000 parasites/microliter

• Hemoglobin concentration >= 7g/dl

• Consent by the patient of patient's adult guardian

• Residence in the locality and willingness to attend for scheduled visits

• Negative urine pregnancy test in women age twelve years and older

Exclusion Criteria:

• Signs of severe or complicated malaria

• altered consciousness

• convulsions

• prostration (inability to sit/stand/suck/drink)

• respiratory distress or breathlessness

• jaundice

• abnormal breathing

• hemoglobinuria

• circulatory collapse

• persistent vomiting (cannot keep down liquids)

• evidence of a diagnosis other than malaria on physical examination

• presence of mixed infection

• presence of severe malnutrition (as evidenced by symmetrical edema involving at least the feet, light hair color, or cachexia)

• contraindications to the antimalarial drugs used, especially history of allergy

• history of receiving a drug with antimalarial activity in the week prior to enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Amodiaquine plus artesunate

• chlorproguanil-dapsone plus artesunate

Locations

Country	Name	City	State
Malawi	Matiki Health Center	Dwangwa	Nkhotakota District
Malawi	Kawale Health Center	Lilongwe	Lilongwe District
Malawi	Machinga District Hospital	Liwonde	Machinga District

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Ministry of Health and Population, Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of abdominal pain on days 1, 2, and 3 in the two treatment groups
Secondary	Rate of adequate clinical and parasitological response at 14 days
Secondary	Rate of adequate clinical and parasitological response at 28 days
Secondary	Mean percent change in blood haemoglobin concentration between day 0 and day 28
Secondary	Incidence of adverse events other than abdominal pain during the period of observation
Secondary	Rate of Early Treatment Failure (per WHO definition)
Secondary	Rate of Late Clinical Failure (per WHO definition)
Secondary	Rate of Late Parasitological Failure (per WHO definition)
Secondary	Percent of patients with a decrease in haemoglobin concentration
Secondary	Percent of patients with a decrease in haemoglobin concentration of >= 2g/dl
Secondary	Prevalence of parasitemia on Day 2
Secondary	Prevalence of parasitemia on Day 3
Secondary	Gametocyte prevalence on Day 14
Secondary	Gametocyte prevalence on day 28