Parasite Clearance and Protection from Infection (PCPI) in Cameroon

NCT06173206 | Completed Phase 3 DMC

• 1 other identifier: 2022-KEP-814
• Study Type: interventional
• Target: 902
• Locations: 1 country
• Sites: 1

Brief Summary

The Cameroon PCPI study will measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP. The total number of participants is expected to be 900 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 450 children will be assigned to the SP group, 250 to the SPAQ group, and 200 to the AS group. The results of this study will allow to measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP.

Conditions

Malaria

Keywords

Malaria; Perennial malaria chemoprevention (PMC); Intermittent preventative treatment of malaria in infants (IPTi); Sulfadoxine-pyrimethamine (SP); Chemoprevention; Drug resistance

Outcome Measures

Primary Outcomes (2)

• Parasite clearance

  Time to clearance of parasite genotypes among SP recipients who were positive on Day 0 by qPCR (presence/absence of Pfdhps I431V) and measured to Day 63

  28 days (total follow up 63 days post SP dose)

• Protection from infection

  (a) Mean duration of SP protection against parasite genotypes determined by Pfdhps gene sequence presence/absence of Pfdhps K540E among SP recipients who were parasite-free on Day 0 by qPCR (b) Mean duration of symptom-free status among SP recipients who were parasite free on Day 0 by qPCR, stratified by parasite Pfdhps genotype at time of febrile malaria episode

  28 days (total follow up 63 days post SP dose)

Secondary Outcomes (3)

• Parasite clearance

  7 days (day 0 until day 7)

• Protection from infection

  35 days (day 0 until day 38)

• Therapeutic efficacy outcomes

  28 days (day 0 until day 28)

Study Arms (3)

Sulfadoxine-pyrimethamine (SP)

ACTIVE COMPARATOR

Groups in the SP group will receive a 7-day course of placebo artesunate (at day -7, -6, -5, -4, -3, -2, and -1), followed by a single course of SP plus placebo AQ for 3 days.

Drug: SP (Macleods Pharmaceuticals Ltd)

Sulfadoxine-pyrimethamine plus amodiaquine (SPAQ)

ACTIVE COMPARATOR

Groups in the SPAQ group will receive a 7-day course of placebo artesunate (at day -7, -6, -5, -4, -3, -2, and -1), followed a single course of placebo SP placebo plus AQ for 3 days.

Drug: SPAQ (Guilin Pharmaceuticals)

Artesunate monotherapy (AS)

ACTIVE COMPARATOR

Groups in the AS group will receive a 7-day course of active artesunate (at day -7, -6, -5, -4, -3, -2, and -1), followed a single course of placebo SP plus placebo AQ for 3 days.

Drug: AS (Guilin Pharmaceuticals)

Interventions

SP (Macleods Pharmaceuticals Ltd) DRUG

Children who weigh \<10kg will receive Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets; children who weigh \>10kg will receive 500mg sulfadoxine plus 25mg pyrimethamine

Sulfadoxine-pyrimethamine (SP)

SPAQ (Guilin Pharmaceuticals) DRUG

Children will receive 500mg sulfadoxine plus 25mg pyrimethamine as one tablet, and 153mg amodiaquine (as hydrochloride) as one tablet on Day 0, and Children will 153mg amodiaquine (as hydrochloride) as one tablet on days 1 and 2.

Sulfadoxine-pyrimethamine plus amodiaquine (SPAQ)

AS (Guilin Pharmaceuticals) DRUG

Children will receive 4 mg/kg/day for 7 days

Artesunate monotherapy (AS)

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Be 3-5 years old
• Exhibit no symptoms of malaria
• Have parents/guardians willing to have their child participate in all follow-up visits and seek care from study staff
• Reside in the study catchment area

You may not qualify if:

• Have evidence of acute illness as determined by clinical examination
• Exhibit symptoms of malaria (axillary fever ≥ 37.5 °C and / or history of fever in past 48 hours)
• Have known allergy to study medications
• Have received antimalarial treatment or azithromycin within 28 days prior to screening
• Be concomitantly receiving co-trimoxazole (trimethoprim-sulfamethoxazole)
• Be categorised as severely malnourished according to WHO child growth standards

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Malantouen District Hospital Catchment Area

Magba, Cameroon

Location

Related Publications (31)

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MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• R Matthew Chico, MPH, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Fully placebo controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Groups 1-2 will receive a 7-day course of placebo artesunate; Group 3 will be given a 7-day course of active artesunate. This will span Day -7, -6, -5, -4, -3, -2, and -1. Then, on Day 0, children in Groups 1-2 will receive a single course of malaria chemoprevention, whereas Group 3, having completed a 7-day course of AS will receive placebo SP.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: June 10, 2024
• Primary Completion: December 25, 2024
• Study Completion: March 5, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-06

Locations

CA (1)