TIPTOP Sulfadoxine-pyrimethamine (SP) Drug Resistance Study

NCT03998839 | Completed FDA Drug

• 1 other identifier: TIPTOP_DRS_2019
• Study Type: observational
• Target: 7,200
• Locations: 4 countries
• Sites: 4

Brief Summary

The main objective of this study is to monitor SP resistance via molecular markers in the context of the TIPTOP project implementation of community distributed SP for women during pregnancy. The specific objective is to detect trends over time in the proportion of symptomatic children with a positive rapid diagnostic test (RDT) residing in the areas where C-IPTp is implemented who carry parasites with dhfr/dhps mutations compared to those in control areas with no community SP distribution.

Conditions

Malaria in Pregnancy

Keywords

drug resistance; Sulfadoxine-pyrimethamine

Outcome Measures

Primary Outcomes (2)

• change in prevalence of molecular markers associated with SP resistance at 36 months

  change in prevalence of molecular markers associated with SP resistance (codons 108, 51 and 59 in dhfr and 437, 540 and 581 in dhps) in blood samples collected from symptomatic children under five years with a positive RDT attending the selected health facilities at 36 months (baseline to endline)

  baseline to endline (approximately 36 months later)

• change in prevalence of molecular markers associated with SP resistance at 18 months

  change in prevalence of molecular markers associated with SP resistance (codons 108, 51 and 59 in dhfr and 437, 540 and 581 in dhps) in blood samples collected from symptomatic children under five years with a positive RDT attending the selected health facilities. from baseline to midline (18 months)

  baseline to midline (approximately 18 months later)

Study Arms (2)

Intervention

Children tested will live within an area targeted for community IPTp distribution for pregnant women.

Other: Community distribution of Sulfadoxine-pyrimethamine (SP)

Control

Children tested will live within an area NOT targeted for C-IPTp, but will live in an area nearby.

Interventions

Community distribution of Sulfadoxine-pyrimethamine (SP) OTHER

Community health workers will distribute SP to pregnant women, targeting at least three times during pregnancy.

Also known as: C-IPTp-SP

Intervention

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be children under five years of age attending the selected health facilities in the intervention and control areas.

You may qualify if:

• Children under five years of age.
• Being resident in the project area at the time of the survey.
• Clinical signs and symptoms suggestive of malaria infection: fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours.

You may not qualify if:

• Not willing to provide informed consent
• Signs or symptoms of severe malaria

Sponsors & Collaborators

• Jhpiego: lead
• Barcelona Institute for Global Health: collaborator

Study Sites (4)

Kenge District, Community Setting

Kenge, Kwango, Democratic Republic of the Congo

Location

Mananjary District, Community Setting

Mananjary, Fianarantsoa, Madagascar

Location

Nhamatanda District, Community Setting

Nhamatanda, Sofala, Mozambique

Location

Ohaukwu District, Community Setting

Ohaukwu, Ebonyi State, Nigeria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

During the surveys, blood samples will be collected onto filter papers (dried blood spots). The surveys will be undertaken in the intervention area (the initial area of implementation of C-IPTp) and one control area (with no C-IPTp) in each country (Figure 1). C-IPTp-SP delivery in the area of initial implementation will start immediately after baseline surveys and sample collection. The sample collection will be performed in four selected first level of care health facilities in the intervention area and four health facilities in the control area. The key markers to be monitored are dihydrofolate reductase (dhfr) triple mutation (codon 108, 51 and 59) together with triple P. falciparum dihydropteorate synthetase (dhps) mutations at codons 431, 437, 540, 581 and 613.

Study Officials

• Elaine Roman, MA

  Jhpiego

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: March 5, 2018
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1); MA (1); MO (1); DE (1)