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Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants
Phase 3 trial testing Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy in Malaria in 300 participants. Completed in 14 May 2018.
| Lead sponsor | Grant Dorsey, M.D, Ph.D. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 23 June 2014 |
| Primary completion | 14 May 2018 |
| Estimated completion | 14 May 2018 |
| Sites | 1 location across Uganda |
Grant Dorsey, M.D, Ph.D. — full company profile →
16 and older, female only, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria.
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 49 | |
| Mothers - 3 Dose DP | 30 | |
| Mothers - Monthly DP | 26 |
Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days.
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 0.95 | |
| Mothers - 3 Dose DP | 0.31 | |
| Mothers - Monthly DP | 0 |
Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compa
| Group | Value | 95% CI |
|---|---|---|
| 3 Dose SP Pregnancy / 3 Monthly DP Infancy | 0.26 | |
| 3 Dose DP Pregnancy / 3 Monthly DP Infancy | 0.30 | |
| 3 Dose DP Pregnancy / Monthly DP Infancy | 0.00 | |
| Monthly DP Pregnancy / 3 Monthly DP Infancy | 0.43 | |
| Monthly DP Pregnancy / Monthly DP Infancy | 0.03 |
Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compa
| Group | Value | 95% CI |
|---|---|---|
| 3 Dose SP Pregnancy / 3 Monthly DP Infancy | 0.87 | |
| 3 Dose DP Pregnancy / 3 Monthly DP Infancy | 0.88 | |
| 3 Dose DP Pregnancy / Monthly DP Infancy | 0.83 | |
| Monthly DP Pregnancy / 3 Monthly DP Infancy | 1.24 | |
| Monthly DP Pregnancy / Monthly DP Infancy | 0.64 |
Prevalence of placental blood samples positive for parasites by microscopy or LAMP
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 5 | |
| Mothers - 3 Dose DP | 3 | |
| Mothers - Monthly DP | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 19 | |
| Mothers - 3 Dose DP | 3 | |
| Mothers - Monthly DP | 2 |
Prevalence of maternal parasitemia at delivery by microscopy and LAMP
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 5 | |
| Mothers - 3 Dose DP | 1 | |
| Mothers - Monthly DP | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 25 | |
| Mothers - 3 Dose DP | 3 | |
| Mothers - Monthly DP | 1 |
Congenital malformations, spontaneous abortion, LBW (\<2500g), still birth, pre-term delivery
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 19 | |
| Mothers - 3 Dose DP | 19 | |
| Mothers - Monthly DP | 9 |
Prevalence of routine hemoglobin measurements \< 11 g/dL
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 94 | |
| Mothers - 3 Dose DP | 72 | |
| Mothers - Monthly DP | 61 |
Any treatment for malaria meeting criteria for severe malaria or danger signs
| Group | Value | 95% CI |
|---|---|---|
| 3 Dose SP Pregnancy / 3 Monthly DP Infancy | 0.022 | |
| 3 Dose DP Pregnancy / 3 Monthly DP Infancy | 0.024 | |
| 3 Dose DP Pregnancy / Monthly DP Infancy | 0.000 | |
| Monthly DP Pregnancy / 3 Monthly DP Infancy | 0.035 | |
| Monthly DP Pregnancy / Monthly DP Infancy | 0.000 |
Admission to a hospital for pediatric inpatient care for any reason
| Group | Value | 95% CI |
|---|---|---|
| 3 Dose SP Pregnancy / 3 Monthly DP Infancy | 0.043 | |
| 3 Dose DP Pregnancy / 3 Monthly DP Infancy | 0.036 | |
| 3 Dose DP Pregnancy / Monthly DP Infancy | 0.089 | |
| Monthly DP Pregnancy / 3 Monthly DP Infancy | 0.082 | |
| Monthly DP Pregnancy / Monthly DP Infancy | 0.043 |
Proportion of urgent blood smears positive for gametocytes
| Group | Value | 95% CI |
|---|---|---|
| Mothers - 3 Dose SP | 4 | |
| Mothers - 3 Dose DP | 1 | |
| Mothers - Monthly DP | 3 |
Proportion of routine monthly samples positive for parasites by LAMP. Proportion of routine samples (LAMP or blood smears) positive for asexual parasites.
| Group | Value | 95% CI |
|---|---|---|
| 3 Dose SP Pregnancy / 3 Monthly DP Infancy | 59 | |
| 3 Dose DP Pregnancy / 3 Monthly DP Infancy | 25 | |
| 3 Dose DP Pregnancy / Monthly DP Infancy | 7 | |
| Monthly DP Pregnancy / 3 Monthly DP Infancy | 52 | |
| Monthly DP Pregnancy / Monthly DP Infancy | 4 |
Time frame: For women, from study drug initiation to 6 weeks postpartum or last observed date in study. For children, from study drug initiation to 4 weeks after last dose of study drugs.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Mothers - 3 Dose SP | Mothers - 3 Dose DP | Mothers - Monthly DP | Infants - Monthly DP | Infants - 3 Monthly DP |
|---|---|---|---|---|---|---|
| Congenital Anomaly | Congenital, familial and genetic disorders | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Elevated temperature | General disorders | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Intestinal Obstruction | Gastrointestinal disorders | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | — | — | — | — | — |
| Threatened Abortion | Pregnancy, puerperium and perinatal conditions | — | — | — | — | — |
| Retained products of conception | Pregnancy, puerperium and perinatal conditions | — | — | — | — | — |
| Preeclampsia | Blood and lymphatic system disorders | — | — | — | — | — |
| Pyelonephritis | Renal and urinary disorders | — | — | — | — | — |
| Elevated Alanine Aminotransferase | Renal and urinary disorders | — | — | — | — | — |
| Seizure | Nervous system disorders | — | — | — | — | — |
| Altered Mental State | Psychiatric disorders | — | — | — | — | — |
| Burns | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Neutropenia | Immune system disorders | — | — | — | — | — |
| Malnutrition | General disorders | — | — | — | — | — |
| Dehydration | General disorders | — | — | — | — | — |
| Reaction | System | Mothers - 3 Dose SP | Mothers - 3 Dose DP | Mothers - Monthly DP | Infants - Monthly DP | Infants - 3 Monthly DP |
|---|---|---|---|---|---|---|
| Cough | General disorders | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| Abdominal pain | General disorders | — | — | — | — | — |
| Headache | General disorders | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Conjunctivitis | Eye disorders | — | — | — | — | — |
| Anorexia | General disorders | — | — | — | — | — |
| Malaise | General disorders | — | — | — | — | — |
| Chills | General disorders | — | — | — | — | — |
| Dysphagia | General disorders | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Hypotension | Blood and lymphatic system disorders | — | — | — | — | — |
Most-reported serious reactions: Congenital Anomaly, Anemia, Respiratory distress, Elevated temperature, Cough, Intestinal Obstruction, Diarrhea, Stillbirth.
Data from ClinicalTrials.gov NCT02163447 adverse events section.
This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected pregnant women and the children born to them. The study interventions will be divided into two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of three intermittent preventive therapy in pregnancy (IPTp) treatment arms: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of dihydroartemisinin-piperaquine (DP), or 3) monthly DP. All three interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. In the second phase of the study, all children born to mothers enrolled in the study will be followed from birth until they reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP during pregnancy will receive DP every 3 months between 2-24 months of age. Children born to mothers randomized to receive 3 doses of DP or monthly DP during pregnancy will receive either DP every 3 months or monthly DP between 2-24 months of age. To ensure adequate blinding, children who will receive DP every 3 months will be given DP placebo during the months they will not be taking DP. Children will then be followed an additional year between 24-36 months of age following the interventions. We will test the hypothesis that IPT with DP will significantly reduce the burden of malaria in pregnancy and infancy and improve the development of naturally acquired antimalarial immunity.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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