Non-malarial Febrile Illness in Children in Areas of Perennial Malaria Transmission

NCT01043744 | Completed

• 1 other identifier: CDC-CCID-5597
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the causes of non-malarial febrile illness in children living in an area of perennial malaria transmission and to determine if these children who test negative for malaria by rapid diagnostic test receive any benefit from antimalarial therapy.

Conditions

Malaria; Non-malarial Febrile Illness

Keywords

malaria; presumptive treatment; Integrated Management of Childhood Illness; fever

Outcome Measures

Primary Outcomes (2)

• Hematological recovery (Hb return to normal)

  28, 63, 91 days

• Mean time to next infection

  Weekly

Secondary Outcomes (1)

• Etiologic agent of non-malarial febrile illness

  Day 0

Study Arms (2)

Artemether-Lumefantrine

EXPERIMENTAL

Receive artemether-lumefantrine with direct observation of am dose on days 0, 1, and 2 of study

Drug: Artemether-Lumefantrine

No treatment

NO INTERVENTION

No antimalarial treatment given on day 0.

Interventions

Artemether-Lumefantrine DRUG

Artemether-lumefantrine (Coartem; Novartis) administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine at a dosage of: * 1 tablet (for patients weighing 5-14 kg) * 2 tablets (for patients weighing 15-24 kg)

Also known as: CoArtem, Novartis

Artemether-Lumefantrine

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 to 59 months.
• Present to health facility with fever (oral or rectal temperature ≥38°C or axillary temperature ≥37.5°C) or history of fever in the past 48 hours.
• Have negative rapid diagnostic test for malaria.
• Live within the boundaries of the officially recognized catchment area of Miono Health Center (within approximately 10 km of the health facility).

You may not qualify if:

• Plan to travel or leave the area within the next 3 months.
• Have been treated for malaria in the 2 weeks prior to enrollment.
• Have clinical evidence or history of danger signs: convulsions, lethargy, loss of consciousness, unable to eat or drink, vomiting everything.
• Have severe, life-threatening anemia: hemoglobin ≤5g/ dL.
• Have very low weight for age, severe pneumonia, or very severe disease as defined in the Integrated Management of Childhood Illness algorithms.
• Have a history of sensitivity to artemisinin derivatives or Artemether-Lumefantrine.
• Have previously been enrolled in this study or another ongoing cohort study of malaria treatment options at these health facilities
• Chronic disease requiring ongoing medical care (i.e HIV on cotrimoxazole).

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (2)

Miono Health Center

Miono, Bagamoyo District, Tanzania

Location

Msata Dispensary

Msata, Tanzania

Location

MeSH Terms

Conditions

Malaria; Fever

Interventions

Artemether, Lumefantrine Drug Combination; lactitol

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Meredith L McMorrow, MD, MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• S. Patrick Kachur, MD, MPH

  Centers for Disease Control and Prevention

  STUDY CHAIR

• Larry Slutsker, MD

  Centers for Disease Control and Prevention

  STUDY CHAIR

• Saumu Ahmed, MD

  Ifakara Health Institute

  STUDY DIRECTOR

• Salim MK Abdulla, MD, PhD

  Ifakara Health Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 7, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 11, 2013

Record last verified: 2013-03

Locations

TA (2)